World Class QA and Compliance Practices for Animal Health Manufacturing Companies

Why Should You Attend:

The animal health industry is regulated by a wide variety of agencies in the US and abroad, with requirements that differ from human health products and differ from country to country. Because of the variety of different agencies that regulate the animal health industry, finding and understanding continually changing agency expectations can be challenging.

This webinar is designed to educate attendees on how to design processes that can be used to determine what animal health agencies around the world are looking for from law, guidance, and technical perspectives, and how to ensure CGMP compliance both in an animal health company’s manufacturing sites and in its contract manufacturing organizations (CMOs) and suppliers.

In addition, attendees will learn how to compare their compliance positions and product approvals with other firms in the industry, and how to efficiently design employee GMP training as required by 21 CFR. 211.25 (a).

An extensive list of hyperlinks to websites containing the information important to monitor in the animal health arena will be provided.

Areas Covered in the Webinar:

• The importance of staying informed with changing CGMP expectations
• What animal health regulatory expectations are important to find
• How and where to find the expectations – for example, from FDA, USDA, EPA, APVMA, Health Canada, CFIA, EMA, and others
• The importance of monitoring recalls, import alerts, and compliance actions
• Determining what is important – the human element
• How to turn information into knowledge (Quality Knowledge Management)
• How to repurpose the information for creating GMP training
• How these processes benefits your company

Who Will Benefit:

• Animal Health QA Managers and personnel
• Animal Health Regulatory Affairs Managers and personnel
• Animal Health GMP auditors
• Animal Health GMP audit preparation teams
• Animal Health manufacturing management and personnel
• Animal Health Consultants
• Animal Health Pharmaceutical development
• Animal Health Contract manufacturers

Jerry Chapman
World Class QA and Compliance Practices for Animal Health Manufacturing Companies

Jerry Chapman’s career of nearly 40 years in the pharmaceutical industry has included positions in development, manufacturing, and quality, at the plant, site, and corporate levels at Eli Lilly and Company. Invited speaker at PDA and AAPS.

He designed and implemented a comprehensive “GMP Intelligence” process at Lilly and again as a consultant at a top five animal health firm. The process is designed to identify pertinent GMP regulations, inspection findings, trends, and related information; then analyze the importance to the company, communicate appropriately, and archive that knowledge.

As Chief Information Officer and Senior Editor at International Pharmaceutical Quality (IPQ) for six years, Jerry traveled internationally to conferences, attending sessions and conducting interviews to produce in-depth reports on topics of interest to both industry and regulators in the drug GMP and CMC space. He developed a clear and concise writing style to convey complex ideas and relationships in simple terms.

As a consultant working for a top five animal health firm in 2016 and 2017, Jerry learned about the nuances of the animal health industry, and designed, built, and implemented a real-time quality knowledge management tool based on the output from the GMP Intelligence process. No tool performing the same functions is commercially available. That tool can be re-built and applied in most regulated industries, and is designed to be a “one-stop-shop” for quality regulatory information and knowledge in the company.

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