Meet New Consultant Penny Vyskocil

Penny Vyskocil

Penny Vyskocil is a food safety, regulatory, and quality professional with extensive experience in both manufacturing and retail, inclusive of corporate and plant leadership positions. She has a proven track record of strategic planning, organizational effectiveness, staff development and project execution. Her expertise includes cereal, snacks, dry meals, IQF vegetables, Low Acid Canned Foods (LACF) and milling.

Meet September 2019 Issue of the Month Author

Tom Jonaitis

Tom Jonaitis

Canadian-based Tom Jonaitis works with clients in the food, dietary supplement, consumer product and related industries, providing comprehensive toxicology and regulatory consulting guidance and support. He is an expert in regulatory evaluations including scientific literature hazard reviews and summaries, as well as creating pre-market quality and safety dossiers for novel food and dietary supplement ingredient applications to government agencies – FDA, Health Canada and Australia’s TGA, FSANZ. Tom reviews and evaluates the results of in vitro and in vivo toxicological studies and has additional expertise in pesticide/agricultural chemical regulations, workplace hazard classifications, and spray foam human health risk assessments.

Meet New Consultant Rebecca Harter

Rebecca Harter

Rebecca Harter assists EAS clients with a variety of food safety, labeling and sensory product development challenges in both human and animal food industries. She is well versed in both FDA and USDA regulations including shelf life analysis, product matching, flavor development, thickeners (Hydrocolloids and Starches), managing ingredient density variation in dry blending, freeze-thaw stability, colorants, and spice-extractive conversions. Prior to consulting, Rebecca was the Director of Regulatory, New Products, and Quality at PetAg, Inc.

Meet Issue of the Month Author William Scopa

William Scopa

William (Bill) Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During his 15 years at the ports, he processed import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures addressing such areas as, intellectual property rights, anti-dumping and countervailing duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasion such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies to develop CBP import processing of imports for EPA, FDA, and DEA.

Ron Levine Expands EAS Services Offering with Creation of Expert Witness Training and Consulting on Complex Commercial Matters

Ron Levine

Ron Levine, EAS Independent Consultant and General Counsel of Herrick, Feinstein LLP will lead EAS’ newest training initiative with a comprehensive look at how to be an effective and sought-after Expert Witness.

Ron Levine has over 40 years of experience advising consumer products companies in complex commercial matters. He offers a wealth of services to EAS clients including

  • Litigation research including relevant records and subpoena requests
  • Research on outcomes of litigations involving similar claims
  • Due diligence assessments including claim history of a target company, risk management policies and procedures
  • Preparing for FDA inspections from the perspective of record production and management
  • Preparing and editing reports to federal agencies and other entities

Ron’s latest projects include helping Expert Witnesses strengthen their understanding of the role, expectations and skills required for being an effective expert witness. With topics including 

  • Understanding the discovery process and the role of the expert
  • The engagement process of becoming an expert
  • How experts are utilized in investigations, trials, and arbitrations
  • Projecting expertise as part of written reports and oral testimony 
  • The business of being an expert witness 

Ron is a pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, where he advises on class action litigations and investigations, including labeling, FSMA, advertising claims, product recalls, FDA regulations, new technologies such as 3-D printing and block chain and many others.

Additionally, Ron has developed EAS’s newest seminar on how to become and strengthen skills as an expert witness. This seminar, in Alexandria, VA and offered remotely will be November 6m 2019. For more details see EAS in Action.

Meet New Consultants for July 2019

Rama Narasimhan

Ramakrishnan Narasimhan (aka ‘Rama’) is a versatile, knowledgeable and competent professional with over 35 years of management experience in the manufacturing sectors pertaining to food, pharmaceutical and dietary supplement industries. He has wide ranging experience in designing, developing, guiding and auditing customized and standard product safety and quality system standards. His ‘think outside the box’ approach to solving complicated technical issues and problems enables novel solutions for clients. He is a frequent invited speaker in the area of product safety (food, pharmaceutical and dietary supplements) in international and domestic conferences.

Rama Narasimhan

Angel Suarez

Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University.

Angel Suarez

Meet July 2019 Issue of the Month Author

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Robert Kapp Ph.D.

Meet June 2019 Issue of the Month Author Miguel Montalvo

EAS Consulting Group independent consultant, Miguel Montalvo, is an expert in GMP and GAP assessments for pharmaceuticals, including injectables, solid dosage, OTC topicals and biologics, as well as medical devices and dietary supplements. He has developed, implemented, reviewed, managed and audited quality and GMP compliance functional procedures including those related to laboratory operations, Quality Systems, CAPA, Non-Conformance documentation, Change Control management, calibrations, procedural and documentation controls and internal audit programs. Prior to consulting Miguel worked in industry holding positions at Baxter Healthcare and Bristol Myers Squibb.

Meet New Consultants for June 2019

Tom Jonaitis

Tom Jonaitis

Canadian-based Tom Jonaitis works with clients in the food, dietary supplement, consumer product and related industries, providing comprehensive toxicology and regulatory consulting guidance and support. He is an expert in regulatory evaluations including scientific literature hazard reviews and summaries, as well as creating pre-market quality and safety dossiers for novel food and dietary supplement ingredients applications to government agencies – FDA, Health Canada and Australia’s TGA, FSANZ. Tom reviews and evaluates the results of in vitro and in vivo toxicological studies and has additional expertise in pesticide/agricultural chemical regulations, workplace hazard classifications, and spray foam human health risk assessments.

Veronica Ortiz de Montellano

Veronica Montellano

Veronica Ortiz de Montellano is based in Mexico and offers assistance in foods, packaging and preservation. She is an expert in food design and process developments including structure, formulation and additives including Thermal Process controls and records for Aseptic Processing and Packaging Systems including microbiological testing for Aseptic Production and CIP programs for Aseptic Systems. In addition, she conducts analyses of packaging materials and utensils to analyze stability, migration, contamination, flavor degradation and more.

Meet May 2019 Issue of the Month Author

John J Brennan Ph.D.

John J. Brennan, Ph.D. is a former Senior Project Leader in Global Pharmaceutical Research and Development at AbbVie in North Chicago, Illinois. At Abbvie he served as the Enterprise Leader for 3 Global Asset Development teams accountable for creating and executing development strategies in several therapeutic disciplines including exocrine pancreatic insufficiency, cystic fibrosis and diabetic nephropathy. His areas of interest include First-in-Man, Proof-of-Concept, Proof-of-Principle, and late-stage registration studies and lifecycle management. Prior to joining AbbVie, he worked at Solvay Pharmaceuticals, Inc. in Global Project Management and as a Therapeutic Area Leader in Women’s Health, Men’s Health and Clinical Pharmacology. Dr. Brennan is a graduate of Temple University and received the Ph.D. degree in Pharmaceutical Sciences from the Philadelphia College of Pharmacy and Science (now University of the Sciences).

Meet New Office Manager, Kate Gibson

Kate Gibson is a graduate of UNC Chapel Hill with a degree in Psychology and Peace, War and, Defense. While at university, Kate was involved in the Triangle Institute for Security Scholars and UNC Neural Connections and has a passion for inclusive STEM Education. Prior to EAS she held a position at the UNC Gillings School of Global Public Health, specializing in tobacco marketing regulation research. Kate is originally from Denver, North Carolina.

Meet Issue of the Month Author, Joe Famiglietti

Joe Famiglietti

Independent Consultant, Joe Famiglietti, provides guidance to clients regarding FDA compliance matters. He has performed onsite audits at food manufacturing facilities and evaluated production and quality control operations for compliance with FDA regulations. Joe has experience in inspections of food manufacturing areas including low acid canned foods, acidified foods, infant formula and seafood HACCP. He assists in facility sanitation issues, provides in-house training to employees on food GMP issues and procedures for handling FDA inspections. Prior to consulting, Joe was a Compliance Officer at the FDA New York District, Import Operations Branch in Buffalo.

Meet New Consultants for April 2019

Robert Post, Ph.D., MEd., MSc.

Robert Post

Dr. Robert Post is a former food industry executive, White House and regulatory agency executive, and university instructor with expertise in food science and nutrition. His roles in the food industry have included leading nutrition and regulatory affairs; corporate health and wellness programs; and food and health communications to support marketing and customers/sales. He has also directed legislative affairs, food ingredient specifications and approvals, food product design and innovation, food labeling and nutrition labeling strategies, design, and compliance; and brand communications strategies for customers, consumers, and health professionals. In the Federal sector, Rob directed the agencies that set the Dietary Guidelines for Americans, created MyPlate(.gov), and the national nutrition evidence library, supporting the White House as a key nutrition advisor. All roles involved expert mining of food and nutrition research and setting research pipelines for product design and product and process claims substantiation. Prior to consulting Rob was the Senior Director for Chobani Health and Wellness and Regulatory Affairs. He also served as the Executive Director for Center for Nutrition Policy and Promotion in the U.S. Department of Agriculture.

Heidi Stuttz

Heidi Stuttz

Heidi Stuttz is an expert in biotech and medical device oversight. She assists clients with a variety of projects including R&D programs, FDA submissions, EMEA dossiers, compliance enhancements and quality improvement initiatives. Assisting with product development processes from clinical trials to commercialization, Heidi demonstrates proven success with facilitating product development and moving regulatory programs forward. Heidi is experienced with auditing cGMPs for continuous process improvements, FDA ISO9000, records management as well as laboratory compliance/controls and validation and facilities and utility validation and remediation. She has worked as a Senior Project/Program Manager with Solution Systems and as a Quality Assurance Specialist at Wyeth Vaccines Division. Heidi has a M.S. from Johns Hopkins University, with degree in Biotechnology, Enterprise and Entrepreneurship, and concentration in Legal/Regulatory.

William Scopa

William Scopa

Mr. Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During 15 years at the ports, he processed both the import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures. These policies and procedures addressed such areas as, Intellectual Property Rights, Anti-Dumping and Countervailing Duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasion such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies and he worked with the other agencies to develop CBP import processing of the other agency imports for such agencies as EPA, FDA, and DEA. These processes included clearing other agency cargo under the Automated Commercial Environment (ACE).

Jan Janson

Jan Janson

Jan Janson is a quality consultant who provides assessments and recommendations on QMS development, Quality and Supplier Management. He conducts internal and supplier audits, develops product quality initiatives, supports CAPA and complaint analysis and more. In addition, Jan has extensive experience with audits against GMPs, Process Validation Reviews including process, software and methods and helps firms develop protocols for FDA 820, ISO 3485 compliance. Prior to consulting Jan was a Quality Manager at Biomet and Senior Quality Supplier Engineer at Medtronic.

Joel Martinez

Joel Martinez

As a former certified ORA BIMO FDA Investigator, Joel Martinez has completed 20-25 BIMO inspections in all therapeutic areas, interacting with CDER’s Office of Scientific Investigations (OSI) medical reviewers and BIMO Office of Compliance personnel for CBER, CDRH and CVM. He has significant experience in recognizing and understanding significant inspectional observations which would warrant further regulatory action and assists clients with understanding critical areas for a Sponsor/CRO in terms of being compliance with applicable 21 CFR regulations. Joel also conducts GLP audits domestically and internationally gaining inspectional experience of non-clinical laboratories.

EAS Welcomes New Consultants in March 2019

Janet Collins, Ph.D.

Dr. Janet Collins assists EAS clients with all matters of food regulatory compliance issues. Her expertise includes product development with an eye towards global agricultural advocacy, appreciation for diversity, and strong expertise in human health science, nutrition and food regulation, and systems for global food acceptance. Janet demonstrates strong global communications/advocacy and leadership with measurable and collaborative results. She recently retired from the position of Executive and Senior Vice President, Science and Regulatory Affairs at CropLife America and was the President of the Institute of Food Technologists from 2008-2015.

Janet Collins PhD

Sophia Lily

Sophia Lily has over 25 years of experience in the regulated pharmaceutical, nutraceutical and food industry Quality Control, Quality Assurance. She is based in India and is experienced in handling inspections, validations, vendor audits and training. She routinely works with, including training, personnel in a range of GMP topics including Data Integrity. With expertise including GMP compliance, gap analysis and remediation and development of roadmaps to compliance, she has successfully implemented effective quality management systems for many companies both small and large.

Sophia Lily

Jay Mansour

Jay Mansour is a seasoned Medical Device regulatory consultant with 20+ years of experience. He has successfully filed more than 100 510(k) clearances across many technologies and assists clients with QMS turnkey projects, including personnel training, and CE marking products as well as responding to FDA’s 483 and warning letters. He is an expert in Process Validations (software, sterilization and more).

Jay Mansour

Jeffrey Roberts

Jeffrey Roberts is an expert in software and systems auditing/validation including compliance with 21 CFR Part 11, 21 CFR Part 820 and ISO-13485. He writes Software Development Life Cycle (SDLC) documents including Validation Compliance Plan (VCP), Functional Requirements Specification (FRS), System Design Specification (SDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).

Jeffrey Roberts

George Yanulis, Ph.D.

Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.

George Yanulis PhD

Meet March 2019 Issue of the Month Author

Kathy Knutson, Ph.D.

Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Kathy Knutson PhD

Meet New Consultant for February 2019

Ronald J. Levine

Ron Levine has 40 years of experience advising consumer products companies in complex commercial matters. In addition to providing consulting services for EAS, he serves as the General Counsel of Herrick, Feinstein LLP, a law firm with offices in New York and Newark, NJ. He has practiced with Herrick since 1984, where he was a partner from 1985-2018. He served as Chair of the firm’s Litigation Department for 15 years.

A pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, and advises on class action litigations and investigations, including serving as an expert witness, related to labeling, the Food Safety Modernization Act (FSMA), advertising claims, product recalls, FDA regulations and other concerns.

The EAS Expert Witness team is greatly enhanced with the addition of Ron. By strategically matching the regulatory purview of the case at hand with our former high-level FDA and industry executives, EAS offers in-depth analysis of FDA and other Federal and state laws as well as standard industry best practices. Ron, along with Steve Armstrong, EAS Independent Advisor for Food Law and Regulation and former Chief Counsel for Campbell Soup Company and Bruce Silverglade, an EAS Independent Consultant and a Principal with the law firm Olsson Frank and Weeda Terman Matz, PC, lead the EAS Expert Witness team of consultants providing detailed and critical services to firms in all FDA commodity areas.

Ron Levine

Meet New Consultants

Timothy Morck, Ph.D.

Timothy Morck provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. Dr. Morck’s career includes clinical nutrition practice, research, and medical school faculty appointments, scientific association management, entrepreneurial personalized nutrition start-ups, and executive and senior management positions at several global food, nutrition and pharmaceutical companies including The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs. The interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him. He received a B.S. in animal science from Penn State University, followed by MS and Ph.D. degrees in nutrition (biochemistry & physiology minors) from Cornell University.

Paula Trumbo, Ph.D.

Paula Trumbo works with clients on food and dietary supplement labeling, claims, and other nutrition related issues for compliance with FDA regulations. Prior to consulting, she led FDA’s Nutrition Science Review Team responsible for the pre-market review of the scientific evidence for food labeling, including health claims, meeting the definition of dietary fiber, and amendments to the Nutrition and Supplement Fact label. She was the US delegate to the Codex Committee on Nutrition and Foods for Special Dietary Uses. Prior to joining the FDA, Dr. Trumbo served as Study Director for a number of study panels at the Institute of Medicine’s Food and Nutrition Board and was Associate Professor of nutrition at Purdue University. Dr. Trumbo has a PhD in biochemistry with minor in nutrition.

Issue of the Month – Tamika Cathey

Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and works to design improvement programs based on findings. Tamika has a B.S. in Biology from Greensboro College in North Carolina. Prior to consulting she held positions such as Associate Director, Regulatory Affairs for Charles River Laboratories, and Consumer Safety Officer at FDA’s Atlanta District. She is a certified auditor with the Natural Products Association and holdsFDA Level II certifications for the Clinical Bioresearch Monitoring Auditor and Drug Auditor Program.

Tamika Cathey

Tamika Cathey

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

Heather Neves Duncan Fairman

Heather Neves Duncan Fairman

Heather Fairman

Ms. Fairman brings nearly 30 years of experience in QA/QC and regulatory compliance from her leadership roles in FDA regulated industries. She was formerly director of Corporate QA and regulatory compliance and the chief safety officer at Natural Organics, Inc., a New York based dietary supplement manufacturer. She has vast experience in establishing, reviewing and executing thorough SOPs, and in handling FDA audits, issues and responses.

Meet Issue of the Month Author Amy Scanlin, M.S.

Amy Scanlin is a marketing coordinator and staff writer for EAS, providing technical support and coordination of EAS educational outreach seminars, webinars, and other communications. She has been with EAS since 2012 and prior had a career in the wellness industry, focusing on management and operations. She has a master’s degree in Health Promotion Management and has been a frequent contributor to industry publications on a variety of topics pertaining to regulations and research.

Meet New Consultant Greg Weilersbacher

With 25 years of industry experience, Greg Weilersbacher has successfully managed Quality Assurance, Quality Control, Analytical Development, Materials Management, GMP Manufacturing, GMP Facilities and Utilities Validation, and Facility Design and Construction Management in CMOs, biotechs and pharmaceutical companies. He has hosted FDA Pre-Approval Inspections and has led numerous European QP inspections of GMP facilities. Mr. Weilersbacher brings practical application of root causes analysis to Deviations and CAPAs and adds significant value to the execution of Supplier Qualifications, Regulatory Audit Preparation, Internal Audits, Training Systems and the evolution of a company’s Quality Systems.

Meet Issue of the Month Author

Bryan Armentrout is an expert in dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, and crisis management, and process improvement. Prior to consulting he was the Vice President of Quality Assurance and Food Safety with Boulder Brands and the Vice President of Quality Assurance and Food Safety at CSC Sugar, LLC. He has a history of benchmarked success leading companies to more efficient and compliant processes.

Meet New EAS Intern, Neha Mookuparambil

EAS is very pleased to welcome our new intern from Georgetown University, Neha Mookuparambil, who is completing an M.S. in Biotechnology.  Her career interests include the fields of Drug Regulatory Affairs, Clinical Research, and Biopharmaceutical Business Development. Prior to Georgetown, she completed a PharmD degree at the Bharati Vidyapeeth University in Pune, India.  She has worked as a healthcare blogger and intern clinical pharmacist at the Bharati Hospital and Research Centre. 

Meet New EAS Consultants

Charlotte Peyton has 30 years of industry experience in analytical chemistry working under FDA, EPA and Colorado Marijuana Enforcement Division regulations. She has been a bench chemist, method development chemist and overseen quality management. She has extensive laboratory experience as well as experience with stability programs, cleaning validations, process validations, and SOPs.

Steven Kurtz supports EAS dairy clients with the interpretation of regulations and development of policies to maintain compliance with FDA, USDA and state requirements. He has an in-depth understanding of dairy equipment and processes including NCIMS, 3-A Sanitary Standards.

Issue of the Month Author, Norma Skolnik

This month’s Issue of the Month on Serious Adverse Events Reporting is written by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Meet New Office Manager Jodi Burns

Jodi Burns

Office Manager, Jodi Burns, has extensive management experience in non-profits and for-profit firms, overseeing projects, human resources and developing policies and procedures. She has worked for organizations such as Clear Chanel Radio, Noell Clevenger & Company, CBS Radio, Loving Couples, Loving Children, Inc., among others in her career. Jodi is the front-line manager of the EAS home office and provides assistance to both consultants and clients in a variety of areas.

 

 

Meet New EAS Consultants

Norris Alderson, Ph.D.

Norris Alderson, Ph.D.

Norris Alderson is an expert in the approval process for veterinary products and assists clients with understanding FDA guidance for data requirements for animal drugs to include additives for animal feeds and process for review by FDA. He also helps clients understand processes for interacting with FDA in the development of products and has experience in managing and understanding functions of institutional review boards including the National Nanotechnology Coordination Office. Prior to consulting, Dr. Alderson spent his career at FDA, most recently as the Associate Commissioner for Science and the Director of the Office of Science and Health Coordination.

Carl Custer

Carl Custer

Carl Custer is an expert in HACCP, microbiology of dried meat products and special processes for retail foods and spent his career at USDA/FSIS investigating foodborne outbreaks. He consults in problem-solving on issues including contamination by Listeria spp., Salmonella, and foreign materials and serves as an expert witness for legal firms on spoilage factors.

John Sawyer

John Sawyer

John Sawyer is a regulatory and quality professional with over 30 years of experience in the medical device, electronic and aerospace industries. He is a Senior Member of ASQ and a registered Lead Quality Management Systems Auditor with the International Register of Certificated Auditors out of London. His current work focuses on providing FDA QSR, ISO-13485-2016, EU MDD, EU MDR, CMDCAS and other regulatory/quality consulting services.

Randy White

Randy White, Ph.D.

Randy White is a consultant for medical devices, pharmaceuticals, biologics, nutritional supplements. Prior to consulting he worked for WuXi AppTec and Baxter Healthcare Corporation overseeing the performance of toxicology and safety studies to include testing strategy, study design, and animal model development, as well as preparation of toxicology reviews for regulatory submissions and toxicity/risk assessments, study director for GLP studies. He has a Ph.D. in Animal Science Nutrition from Oregon State University.

John Ziobro

John Ziobro

John Ziobro is an experienced professional in the medical device industry. His expertise includes engineering and new product development from concept-through-completion, design controls, design traceability, technical files including 510(k) submissions, device history records, and design dossiers. John’s background includes vast experience in electromechanical design, verification and validation; component selection and vendor audits.

Meet New EAS Intern Shachi Shah

Shachi Shaw

Shachi Shah is an intern at EAS and a graduate from the Georgetown University BioBusiness Master’s Program. Her coursework focused on bioinformatics, Molecular Medicine, cGMPs. Shachi will begin her career in the fall when she begins working at a biotechnology company that develops vaccines protective against malaria.

Meet Issue of the Month Author, James Evans

James Evans

James Evans has more than 30 years of experience as an FDA auditor and specializes in pharmaceuticals, medical devices, biologics, and biotechnology. His expertise includes pharmaceutical inspections, antibiotics, radiopharmaceuticals, parenteral, sterilization, clinical/non-clinical (GLP) laboratory studies, and computer systems validation and pharmacology. In addition, he is well-versed in HACCP inspections for low-acid canned food and infant food manufacturing operations.

Meet New EAS Consultants for August 2019

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

Beth Ann Crozier-Dodson, Ph.D.

Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include teaching and training in microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

Meet Issue of the Month Author and New Independent Consultant, Cindy Beehner

Cindy Beehner has worked as a consultant since 1997, specializing in GMP requirements for food, dietary ingredients, dietary supplements and pharmaceuticals. Ms. Beehner performs due diligence assessments as well as procedures and documentation required for certifications for groups such as Therapeutic Goods Administration (TGA), World Health Organization (WHO), United States Pharmacopeia (USP) and National Food Producers Association (NFPA). She has a Bachelor of Science, Chemistry and Clinical Psychology from Moravian College, Bethlehem, PA.

Meet Issue of the Month Author Charles Otto, III

Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

Meet New EAS Consultants

Philip Scharago is a pharmaceutical consultant with extensive knowledge of ISO 13485, 14971, QSR GMP 820, ICH, MDD/EU, ICH, CGMP, Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. He has more than twenty-five years working in the Medical Device and Pharmaceutical Industries in the areas of Quality Assurance and Regulatory Affairs and extensive experience developing and improving quality systems to meet FDA requirements and remediation of FDA-483 observations and Warning Letters.

Kristen Steel is a regulatory professional with a strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling requirements, as well as an international framework as it relates to product labeling.

Beth Ann Crozier-Dodson, Ph.D., is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Dr. Crozier-Dodson has spoken in, designed and taught customized microbiology/food safety workshops across the globe. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

In Memoriam: Bill Ment

Bill Ment who was a long-time friend and consultant to EAS. Bill had a 34-year career at FDA, where in his last agency role he served as the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products. Following FDA retirement in 1999, he began consulting with AAC Consulting Group and Kendle Regulatory Affairs, from which EAS Consulting Group grew. Thanks to Bill’s expertise and outstanding reputation both at FDA and as a consultant, he was quickly asked to join the ranks of EAS Independent Advisors, overseeing GMP Auditing Services. Bill performed many pharmaceutical, laboratory and dietary supplement audits of API and finished product manufacturers, and helped companies improve their laboratory and QC/QA operations. He was also instrumental in the development of the EAS Dietary Supplement Good Manufacturing Practices seminar, which has become an EAS flagship training program. Most importantly, Bill was a great friend to many at EAS where he often mentored new consultants, helping them to make the transition from industry or FDA to the consulting world. He was an easy-going man of great integrity, with an unbelievable work ethic and he will be truly missed. Please keep Bill’s family in your prayers as they go through this difficult time. Should you wish to make a contribution in Bill’s memory, here is a list of charities with meaning to Bill and his family.

Meet New EAS Consultants June 2018

Charles Otto

Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel program, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

Robert Kapp Ph.D.

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including chemical, petrochemical, food, consumer products, and pharmaceuticals. He has experience in preclinical program study design, study reports, occupational and industrial toxicology, evaluating clinical and product safety data; in training and managing staff in laboratory operations; evaluating contract research organizations and various compliance issues in the US as well as abroad. Dr. Kapp has experience in writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Sanaullah Khan, Ph.D.

Sanullah Khan has a Ph.D. in Analytical Chemistry from the University of Kansas, MBA from Rutgers University and MS in Bioscience Regulatory Affairs from Johns Hopkins University. He has worked in the Pharmaceutical industry since 1996, in the areas of R&D, technical operations and worldwide quality and compliance. His expertise in GLPs and GMPs range from discovery to filing and post-market quality oversight. R&D functions include developing and validating analytical methods to support non-clinical and clinical studies, and Worldwide Quality and Compliance responsibilities have included investigation of out of specification (OOS) and out of trend (OOT) results. As a quality consultant, Dr. Khan provides support for overseeing QC laboratory operations, conducts investigations of OOS results and manufacturing deviations and data integrity. He performs manufacturing and laboratory equipment qualifications, cleaning validation and batch record review, drafting of SOPs, qualification protocols and Master Production Records for pharmaceutical and Biologics companies.

John J. Brennan, Ph.D.

John J. Brennan, Ph.D. is a former Senior Project Leader in Global Pharmaceutical Research and Development at AbbVie in North Chicago, Illinois. At Abbvie he served as the Enterprise Leader for 3 Global Asset Development teams accountable for creating and executing development strategies in several therapeutic disciplines including exocrine pancreatic insufficiency, cystic fibrosis and diabetic nephropathy (SONAR Phase 3 Trial). His areas of interest include First-in-Man, Proof-of-Concept, Proof-of-Principle, and late-stage registration studies and lifecycle management. Prior to joining AbbVie, he worked at Solvay Pharmaceuticals, Inc. in Global Project Management and as a Therapeutic Area Leader in Women’s Health, Men’s Health and Clinical Pharmacology. Dr. Brennan is a graduate of Temple University and received the Ph.D. degree in Pharmaceutical Sciences from the Philadelphia College of Pharmacy and Science (now University of the Sciences).

Robert P. Lavieri

Robert P. Lavieri is an expert in the development and delivery of Governance programs for the development of sustainable compliance systems. His expertise in design, development, and implementation of Standard Operating Procedures, Best Practices, Good Manufacturing Practices (CGMP’s) and technical expertise across a broad range of compliance areas such as OSHA, EPA, FDA (Food Safety), DOT enable him to offer benchmarked results for clients. Mr. Lavieri is also a frequently requested trainer, educating manufacturers on HAZWOPER, Process Safety Management, Risk Management Program, Process Hazard Analysis (HAZOP, FMEA, FMCA, etc.) as well as Hazardous Communication (chemical safety).

Meet Issue of the Month Author Dawn Wydner

Dawn Wydner, consults in pharma and medical devices, providing proactive compliance and application of quality oversight in all aspects of operational strategy, coordination and conduct. Prior to consulting she was the Senior Director of BioResearch, Quality, and Compliance at Janssen Research & Development, LLC where she oversaw GxP regulatory requirements and compliance issues and provided guidance on GCP/GLP mock inspections and audits of clinical investigators, CROs, SMOs, sponsors/monitors, animal laboratories and IRBs. She is a sought-after speaker, sharing her expertise on topics such as Sponsor Monitor Inspection Management and Expectations, Inspection Readiness and FDA Trends, Analytical Risk Management.

EAS Welcomes New Independent Consultants

Dawn Wydner, Ph.D.

Dawn Wydner, Ph.D., consults in pharma and medical devices, providing proactive compliance and application of quality oversight in all aspects of operational strategy, coordination and conduct. Prior to consulting she was the Senior Director of BioResearch, Quality, and Compliance at Janssen Research & Development, LLC where she oversaw GxP regulatory requirements and compliance issues and provided guidance on GCP/GLP mock inspections and audits of clinical investigators, CROs, SMOs, sponsors/monitors, animal laboratories and IRBs. She is a sought-after speaker, sharing her expertise on topics such as Sponsor Monitor Inspection Management and Expectations, Inspection Readiness and FDA Trends, Analytical Risk Management.

Richard White

Richard White is a former Director of Codex and International Standards Policy at the Grocery Manufacturers Association. Prior to GMA, he had a career serving US public interests as the Senior Director, Sanitary and Phytosanitary Affairs at the Office of the US Trade Representative and as the Senior Advisor for International Activities in the Office of the Assistant Administrator for Prevention, Pesticides and Toxic Substances at the Environmental Protection Agency. As a consultant he provides expert advice and services regarding international standards, national policies and regulations on food safety and animal and plant health with a focus on the activities of the Codex Alimentarius Commission (CAC) and its subsidiary bodies.

 

Andrea Yablunosky

Andrea Yablunosky’s focus is product development, labeling compliance, and risk mitigation for issues pertaining to USDA/FSIS. With a background in food science and nutrition she is well-versed in policy development, product reformulations and promotions, recall preparedness and effective recall management. Prior to consulting Andrea was the Director of Government Affairs at ConAgra Foods where she advised the company business units on implications of FDA and USDA policy objectives.

Dee Duffy

Dee Duffy has over thirty years of experience in regulatory food labeling and a passion for saving companies money by helping them comply with public health information regulatory standards. She has worked with numerous food manufacturers like Johnsonville and Birchwood Foods on products available in grocery outlets like Kroger, Publix, and H-E-B, to help ensure new product packaging can go on shelves with minimal risk.

Bryan Armentrout

Bryan Armentrout is an expert in international CPG, and dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, and crisis management, and process improvement. Prior to consulting he was the Vice President of Quality Assurance and Food Safety with Boulder Brands and the Vice President of Quality Assurance and Food Safety at CSC Sugar, LLC. He has a history of benchmarked and proven success leading companies to more efficient and compliant processes.

Meet Issue of the Month Author Gustavo Gonzalez, Ph.D.

Gustavo Gonzalez, Ph.D. is a Food safety, regulatory compliance and quality leader with 24 years’ experience driving strategic planning and implementation the policies and procedures that govern food safety and quality programs that align with current and industry food safety, quality, and R&D trends and best practices. He is an expert in a range of food sectors, quality and safety systems and other programs such as allergen control/prevention, auditing functions, distribution systems, environmental monitoring, FSMA, GFSI, retail operations, sanitation, team building, and training. Prior to consulting, Dr. Gonzalez was the Corporate Director of Food Safety and Regulatory Compliance for Jack in the Box, Inc. He has a Ph.D. in Meat Science from Iowa State University.

We invite you to join Dr. Gonzalez on June 6, 2018, at 1:00 pm Eastern when he will present a webinar on the requirements of the Foreign Supplier Verification Program in Spanish. Click here to reserve your seat.

Meet Issue of the Month Author, Susan Crane

Susan CraneSusan Crane is EAS’ Independent Advisor for OTC Drugs and Labeling. She is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products and has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution. Susan’s guidance for clients ranges from Good Manufacturing Practices, Labeling, Enforcement Policy (Recalls), Dietary Supplement and Nonprescription Drug Consumer Protection Act, Consumer Product Safety Commission (CPSC) – Poison Prevention Packaging Act, Consumer Product Safety Improvement Act, and OSHA Hazard Communication Standards. She is a frequent instructor for CHPA’s OTC Academy, presents webinars and publishes articles in industry publications on a variety of OTC related issues.

EAS Welcomes Two New Consultants

Kathy Knutson, Ph.D.

Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Rudy Westervelt

Rudy Westervelt works in foods with a particular focus on solving problems related to dairy food quality, loss reduction, employee safety results, throughput, and cost control. Rudy is a Board Member of World Food Trace, Inc., a non-profit creating a tool to instantaneously trace products through the global food supply chain and is a member of the Global Food Traceability Pilot Project which developed a universal coding system for manufactured food products with a searchable database for rapid identification of source in cases of contamination. Rudy has a Masters of Science in Meat Science and Muscle Biology from the University of Connecticut and an undergraduate degree in Animal Science from Cornell University. Prior to consulting, Rudy spent his career at the Kroger Company.

Meet Issue of the Month Author Tim Hansen

EAS Independent Consultant Tim Hansen is a former director of the seafood division in FDA’s Center for Food Safety and Applied Nutrition and a former director of the seafood inspection program for the National Oceanic and Atmospheric Administration (NOAA) Fisheries. He previously served in other roles in NOAA’s seafood program, prior to which he was a product supervisor for the Fleischmann’s Yeast Division, Nabisco Brands, in Sumner, WA. Earlier in his career, he served as a supervisor in the New England Fish Company, Seattle, WA and subsequently as a QA manager for British Columbia Packers in South Bend, WA and in Naknek, Alaska. Tim consults with clients on all matters of HACCP, with a particular focus on seafood.

Increased Availability for Independent Consultant, Robert Burns, Ph.D., Expert in Infant Formula

Though not a new independent consultant for EAS, we are pleased that Robert “Robbie” Burns, Ph.D., an expert in infant formula is now more readily available to EAS clients after stepping down from the Grocery Manufacturers Association as former Vice President of Health and Nutrition Policy. Dr. Burns is an asset to EAS Clients looking to develop infant formula and his readiness to assist clients greatly enhances our roster of food science experts. Prior to GMA, Dr. Burns was the former Global Nutrition and Scientific Affairs Director at Cadbury Schweppes where he worked to establish consistent global standards and strategies for the improvement of new product pipelines and capacities to reliably deliver nutrition-based product and communication initiatives. Prior to Cadbury, he was at Mead Johnson Nutritionals where he worked with Pediatric Nutritionals. Robbie has a Ph.D. in Nutritional Biochemistry from Queens University in Belfast, Ireland with Postdoctoral Research Fellowships at the Universities of Nottingham and Illinois, Urbana-Champaign. He is the author of nearly 50 papers and articles and has been an invited speaker at dozens of international symposiums and conferences.

Meet Issue of the Month Author Elizabeth Campbell

Elizabeth CampbellIndependent Advisor for Labeling and Claims, Elizabeth “Betty” Campbell, is a former Acting Director in the FDA’s Office of Food Labeling who played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s. She joined EAS as a vice president in October 2006 after a 35-year career with FDA. In the role of independent advisor, she provides expert consulting advice and guidance to clients on complex labeling and claims issues including foods, medical foods, and infant formula. Betty has also served as an expert witness in numerous high profile labeling cases.

Meet Regulatory Intern, Yuthika Gokaraju

Yuthika Gokaraju is pursuing her Masters in Biotechnology with an emphasis in BioBusiness at Georgetown University, Washington DC. She has an undergraduate degree in Pharmacy from Osmania University in Hyderabad, India. Yuthika has industry experience working as a student trainee at a nutraceutical company and hopes to expand her knowledge of the FDA regulated industries through the assistance of a variety of projects.

Meet Issue of the Month Author, Brian Nadel

Brian Nadel works with domestic and international clients on matters of FDA compliance and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceuticals (OTC, prescription and APIs). Mr. Nadel conducts quality based audits, mock-FDA inspections and inspection readiness audits to assess site compliance with applicable requirements and assists with FDA-483/Warning Letter remediation and responses as well as general quality system CAPAs. Mr. Nadel has been a consultant since 2012, with prior careers at both FDA and industry. Mr. Nadel was the Senior Director, US Quality & Compliance and GMPs at Sanofi-Aventis, and Senior Compliance Manager, Corporate Quality & Compliance, GMP Compliance Assessment at Forest Laboratories, Inc. Mr. Nadel also worked as a compliance officer and investigator at FDA’s Center for Drug Evaluation and Research.

EAS Welcomes Three New Independent Consultants

Stephen R. Cammarn, Ph.D.

Stephen Cammarn is an expert in pharmaceuticals and personal care products with a particular focus on quality assurance of manufacturing, research and development. Prior to consulting Dr. Cammarn built a career at The Procter & Gamble Company where he oversaw quality assurance and quality control in plants across six continents and had direct oversight in areas such as formulation, process engineering, and technical services. Dr. Cammarn’s doctorate is in Pharmaceutical Science from The University of Cincinnati and his bachelors are in Chemical Engineering from Ohio State University.

Karen Dixon

Karen Dixon consults in the area of tobacco. She has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations and integration within all levels of an organization (Regulatory Affairs, Quality System, OSHA, ISO, Sarbanes-Oxley). Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. Karen has held positions such as Manager, Quality Management System at Altria and Philip Morris USA. She has an MBA from Montreat College in North Carolina and is a Certified Quality Auditor (CQA) with the American Society for Quality.

Gustavo Gonzales, Ph.D.

Dr. Gonzales has a long history of regulatory compliance strategic planning. He is an expert in food safety and quality with a particular expertise in meat sciences and has a 24-year track record of implementing policies and procedures that align with industry R&D trends and best practices at companies such as Jack in the Box and Specialty Foods Group. Dr. Gonzales works in a variety of food sectors on programs such as allergen control/prevention, auditing functions, distribution systems, environmental monitoring, FSMA, GFSI, retail operations, and sanitation. He has a Ph.D. in Meat Science from Iowa State University with certifications as a Food Safety Manager, International Dairy Foods Association HACCP, and is a Lead Instructor for FSPCA Preventive Controls for Human Foods.

Cathryn Sacra Promoted to Director, Labeling and Cosmetics

Cathryn SacraEAS clients who need assistance in the area of labeling and cosmetics are well familiar with Cathryn Sacra, who was recently promoted to Director of Labeling and Cosmetics. Cathryn has been with EAS since 2008, serving in positions of increasing responsibility. She holds an undergraduate degree from Harvard University.

Susan Catloth Joins EAS as New Office Manager

Susan Catloth recently joined EAS as office manager. Susan brings a wealth of organizational and skills and experience to the team and will assist with various projects as well as provide front-line communication and service for those contacting EAS home office. Prior to EAS, she worked at the Motley Fool where she held the positions of Project Manager, Investing Team, and Video Operations Manager. Susan’s skills in video and content production will enable EAS to expand our digital training platforms.