July 9, 2019 – 1:00 PM eastern

Jerry Heaps, EAS Independent Consultant

When pests invade a food facility the consequences for product loss and remediation costs can be exponential. Whether inside or outside, live or dead, in a finished product or raw materials, the need for an Integrated Pest Management System is key to ensuring FSMA compliance, good sanitation and is critical to operations.

Learn common pitfalls many companies make to successfully managing pests in food and warehousing facilities from EAS Independent Consultant, Jerry Heaps, a board-certified Entomologist (BCE) in Urban and Industrial Entomology as well as an internationally qualified trainer in HACCP-based food safety systems.

Assess your facility’s IPM and take actionable steps to correct any deficiencies for a healthier, safer and compliant system. Register today!

About the Presenter:

Jerry Heaps, EAS Independent Consultant

EAS Independent Consultant, Jerry Heap, is a Board Certified Entomologist (BCE) in Urban and Industrial Entomology as well as an internationally qualified trainer in HACCP-based food safety systems. Technical food safety skills in food plant production, supply chain and warehouse food safety management systems, inspections/auditing, National Organic standards and inspections, FSPCA-recognized FSMA “Lead Instructor”, food safety risk analyses and pest control. Both at the Corporate and local level, consults on improving the food safety management systems of food plant and warehouse programs, sanitation practices, GMP’s and pest control/IPM programs.

June 13, 2019 at 1:00 pm eastern

Presented by Bryan Coleman, EAS Senior Director for Drugs and Medical Devices

With more than 80 therapeutic categories, Over-the-Counter (OTC) drug products play an ever-increasing role in health care. FDA’s Center for Drug Evaluation and Research (CDER) working in conjunction with the Office of Regulatory Affairs (ORA) ensures that OTC products are safe to use, appropriately labeled, adverse events reports are filed and that all products are manufactured under the appropriate quality control measures. Generally, the FDA’s first and best opportunity to assess the quality and compliance conformance of an OTC drug will be during an on-site inspection of the manufacturing facility. From a Good Manufacturing Practices (GMP) perspective, manufacturers must recognize that the FDA applies the same, stringent 21 CFR 210 and 211 drug GMP standards to OTC products just as prescription drugs are held to. Thus, OTC drug manufacturers (and contract manufacturers) must maintain vigilance at all times with all aspects of production quality and documentations. From the physical plant and grounds, employee training, testing and specifications, including Out of Specifications (OOS) results management, compliance expectations with 21 CFR 211 are clearly articulated. Register

About the Presenter

Bryan Coleman

Join Bryan Coleman, EAS Senior Director for Drugs and Medical Devices for a complimentary webinar on June 13, 2019 at 1:00 pm eastern where he will discuss the specifics of GMP compliance under 21 CFR Part 211 and common pitfalls that warrant increased FDA attention.

May 14, 2019 1 PM Eastern

Presented by Independent Consultant Jeffrey Roberts

Regardless of the type of industry, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration and requires a verified electronic signature that ensures identity and authenticity. 

Learn the specifics of Part 11 requirements for electronic signatures with Jeffrey Roberts on May 14, 2019. This complimentary webinar will discuss how record keeping is inclusive of a larger focus on GMPs for electronic records that are created, modified, maintained, archived, retrieved, or transmitted as well the specifics of content that must be included in these records for verification and validation. Register here.

About the Presenter

Jeffrey Roberts

EAS Independent Consultant, 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).

May 7, 2019 at 1:00 PM Eastern

Presented by Independent Consultant Norma Skolnik

In the competitive cosmetics world, discerning consumers are carefully considering product purchases to determine which offer the results they are hoping to achieve. In response, the pressure on marketing and labeling teams may entice to push the envelope with regards to product claims. However, words do matter, particularly in the eyes of FDA.

The manner in which labels are worded and claims are made can make all the difference in a cosmetic product inadvertently being marketed as an unapproved drug. Once a company has crossed that line, FDA takes notes and immediate changes to the marketing strategy to correct the errors or the product will be forcefully pulled from the market with potential liability risks for the company and product owners.

Learn how the words used on a cosmetic label can alter the intended meaning of a claim and FDA views on them. Ensure your cosmetic products are labeled and marketed in a compliant manner, offering consumers an accurate understanding of what they can expect and protecting your products from FDA concerns. Join Norma Skolnik on May 7, 2019 for a complimentary webinar and ensure your cosmetic product labeling and claims are compliant with FDA regulations.

About the Presenter

Norma Skolnik

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, cosmetic 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.

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 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

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.