World Class QA and Compliance Practices for Animal Health Manufacturing Companies

Product Id IQW15C6172
Speaker Jerry Chapman
Level Basic & Intermediate
Duration 60 Mins
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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.
Keeping current and compliant is based on understanding and implementing a set of “external GMP surveillance and influence” processes – a set of processes that ensure a GMP manufacturing facility remains compliant with the ever-changing “C” in CGMP. A Process Model will be proposed and discussed, as will be how to find data specific to the animal health industry. Strategies will be discussed on the appropriate communication and archive methods for the outputs from the processes.
An important part of the process is ensuring all relevant information gets to the appropriate levels of the organization, and how it can be repurposed to use as GMP training.
Importantly, the concept of Quality Knowledge Management (QKM) will be introduced, and participants will learn the value of QKM to their organizations and how to build QKM processes based on organizational needs. QKM is not an expensive technology investment. A robust set of processes can be built using relatively simple tools that are probably already in-house.
 
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.
 
• 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
 
  • 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 is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry. His experience includes numerous positions in development, manufacturing, and quality, at the plant, site, and corporate levels. He designed and implemented a comprehensive “GMP Intelligence” process at Eli Lilly and again as a consultant at a top-five animal health firm. Jerry served as Senior Editor at International Pharmaceutical Quality (IPQ) for six years, producing in-depth reports of interest to industry and regulators in the drug GMP/CMC space. He currently does independent consulting for the pharma and animal health industries, and serves as Editor In Chief for Xavier Health.  

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