Category Archives: Webinar

Cutting Edge Technologies & Analytical Methods for Detecting Food Fraud

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November 12, 2019 at 1:00 PM Eastern

Presented by Mehrdad Tajkarimi, Ph.D.

The challenge of detecting Food Fraud has never been greater or more complicated. In part II of our webinar series on Understanding the Food Fraud Puzzle, Dr. Mehrded Tajkarimi will dive deeper into the available technologies for food fraud detection including DNA-based technologies, spectroscopic, chromatographic and other methods as well as examples of their applications.

Join Mehrdad Tajkarimi, Ph.D. on November 12, 2019, at 1 pm eastern to uncover how to stay vigilant in the detection of Food Fraud and how the latest technologies for doing so can protect your consumers and your business.

If you think you Food Fraud detection strategies, think again. New and more robust methodologies provide a wealth of data and greater detail. 

DNA based technology methods:

  • PCR
  • RTPCR
  • Next Generation Sequencing Technology

Spectroscopic methods: 

  • Fourier Transform Infra-Red (FTIR)
  • Dielectric Power Spectroscopy
  • Laser Induced Breakdown Spectroscopy (LIBS)
  • Nuclear Magnetic Resonance (NMR)
  • Raman Spectroscopy
  • Near Infra-Red (NIR)
  • Surface Enhanced Raman Spectroscopy (SERS)
  • Mid IR Spectroscopy
  • UV/VIS absorption
  • FTIR with ensemble learners
  • Impedance Spectroscopy
  • High throughput Raman Chemical Imaging Spectroscopy

Chromatographic methods:

  • HPLC/UV (Ultraviolet)

About the Presenter

Mehrdad Tajkarimi, Ph.D.

EAS independent consultant, Mehrdad Tajkarimi, is an expert in national and international food safety regulations, warehouse and wholesale manufacturing, dairy, grain, poultry and retail industries, HACCP, food defense, ISO 22000, BRC. He assists clients with organic requirements, Food Safety Modernization Act (FSMA), as well as in natural food preservatives and packaging, foodborne pathogenic and spoilage microorganisms characteristics, SPC and shelf life studies.

Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters

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November 7, 2019 at 1 PM Eastern

Robert Fish, EAS Independent Advisor for Quality and Compliance

Though FDA’s 21 CFR 111 Good Manufacturing Practices (GMPs) for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance. The establishment of specifications for components, in-process materials, and finished products; and then testing to those specifications has continuously been the top observation issued by the FDA. Use of a Master Manufacturing Record (MMR) that is executed for each manufactured and packaged batch, and at every batch size, in a Batch Production Record (BPR) has also been a challenge, despite the detailed list of MMR and BPR requirements provided in Subparts H and I of the regulation, respectively. In addition, having a Quality Unit that reviews and approves these specifications and records, as well as all other processes, and conducts necessary material reviews to make scientifically sound disposition decisions is a vital part of the GMP quality system that is frequently missing or inadequate.

Join EAS Consulting Group’ Robert Fish for a look at how the overall industry is complying with 21 CFR 111 through a review of recent FDA observations and Warning Letters. Gain insight to FDA’s enforcement focus as well as trends in problem areas that your firm can proactively address. When FDA shows up for a surprise inspection, you’ll be ready.

Register Today!

About the Presenter

Robert Fish, EAS Independent Advisor, Quality and Compliance

Robert Fish

Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

Navigating CBP and Prior Notice of FDA’s Imported Products

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October 29, 2019 at 1 PM Eastern

William Scopa and Angel Suarez, EAS Independent Consultants

As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.

Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be covered in some detail in this webinar. Qualifying for these “expedited” programs is critical to meeting shipment timelines in order to maintain successful business relationships with U.S. wholesalers and retailers.

As the U.S government increases its focuses on and enforcement of food fraud, food defense, and food safety regulations, existing companies or new companies intending to import food-based products into the US must be aware that requirements have changed substantially over the past year, with many more regulatory obstacles that must be addressed in order to continue a successful import business.

Additionally, of great importance to dietary supplement firms, FSMA gave new authorities to import under Subpart L Foreign Supplier Verification Program for Importers Section1.511 Importing foods subject to dietary supplement CGMP regulations. Under the prior notice all food including dietary supplements are required to file and import admissibility require follow the CGMP plus the FSVP.

Join EAS Consulting Group’s Independent Consultants William Scopa and Angel Suarez for a deep dive into the regulatory challenges of importing FDA regulated products into the US and opportunities for streamlining procedures for companies able to demonstrate a record of safety and compliance.

Register Today!

About the Presenters

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 evasions 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.

Angel Suarez

Angel Suarez

Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role, he had the 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.

How to be an Effective and Sought-After Expert Witness

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November 6, 2019 at 1 PM eastern

Complimentary webinar presented by Ronald Levine, EAS Consulting Group Independent Consultant and General Counsel with Herrick, Feinstein, LLP

As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response.

For attorneys, choosing a knowledgeable and experienced expert witness is of paramount importance. Unlike attorneys who are schooled in the world of litigation, experts often come from academia, the government and industry, and are not familiar with the unique skills required to be an effective witness.

Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-hour complimentary webinar on the role, expectations and required skills for being an effective expert witness.

The webinar will provide an in-depth overview of:

  • 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

Register today!

About the Presenter

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.

Dietary Supplements and FSMA Compliance – Fallacy or Fact?

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April 16, 2019, 1:00 PM Eastern

Presented by: EAS Independent Consultants Heather Fairman & Maury Bandurraga

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to many aspects of the Seven major regulations that were issued by FDA to support enforcement of FSMA. One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF), which requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when materials are sourced internationally which has been estimated to be more than half of all dietary supplement ingredients. Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry including raw material manufacturers and suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid these enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply? What about other FSMA responsibilities like FSVP?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Heather Fairman and Maury Bandurraga for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a food safety plan and what qualifications the PCQI must have in order to be qualified to create and oversee the program, and what is needed to develop an FSVP.

Dietary Supplement OLDs, manufacturers and raw material suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.

Register Today!

About the Presenters

Heather Fairman, EAS Independent Consultant

Heather Fairman

Heather Fairman brings 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. In addition to consulting, Ms. Fairman is a technical advisor to SIDS DOCK IWON herbal/raw material ingredient supply chain portfolio projects. SIDS (Small Island Development States) DOCK Island Women Open Network (IWON), is a Sustainable Energy and Climate Resilience Organization, that is the only small island intergovernmental organization vested with the full powers of the United Nations (UN), comprising almost 40 sovereign countries or one-fifth of the UN membership. Heather is a PCQI and was trained in FSMA-PCHF (Preventive Controls for Human Food) through the FDA accredited FSPCA program. She helps both dietary ingredient suppliers and finished product manufacturers meet compliance.

Maury Bandurraga, EAS Independent Consultant

Muary Bandurraga

Maury Bandurraga has in-depth expertise in quality assurance in a variety of FDA regulated product categories including packaging, food safety and quality, supply chain, labeling and claims. Prior to consulting she was the Food Safety and Quality Assurance Principal Scientist at Kelloggs and Food Supply Chain Food Safety and Quality Assurance Section Head at Procter & Gamble. Maury is both an FSMA and FSVP lead instructor through the FDA accredited FSPCA program and helps food and dietary supplement companies and their supply chains maintain vigilance of safety and compliance with Federal regulations.

OTC Monograph Regulations a Five Part Webinar Series

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Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series starting January 16, 2019.

Later sessions will include topics such as:

  • What makes a drug an OTC and the Monographs Compliance System
  • Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market
  • OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.

Part 1

OTC Drug Monographs, Past, Present, and Future

January 16, 2019

Part 2

OTC Drugs, Labeling and Listing Requirements

February 27, 2019

Part 3

Cosmetics Labeling and Claims Regulations

March 27, 2019