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.
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.
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.
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.
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.
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.
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.
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 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 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, 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 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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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 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’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 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 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.
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.
Susan 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.
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 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.
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.
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.
Independent 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.