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A Holistic Approach to External GMP Surveillance, GMP Training and Quality Knowledge Management
• External GMP surveillance and influence
• A process model
• The importance of the human element
• The communication and archive journey
• Packaging process output for individuals at different organization levels
• Repurposing the work for GMP training
• Incorporating the QKM Element
• How the QKM System is Used and How it Benefits the Company
Overview of the webinar
This webinar is designed to educate attendees on how to design processes that can be used to determine what human health agencies around the world are looking for from law, guidance, and technical perspectives, and how to ensure CGMP compliance both in a pharmaceutical 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.
Who should attend?
- QA managers and personnel
- Regulatory affairs managers and personnel
- GMP auditors
- GMP audit preparation teams
- Consultants
- Pharmaceutical development
- Contract manufacturers
Why should you attend?
External GMP Surveillance and Influence is comprised of a set of processes that ensure a GMP manufacturing facility remains compliant with the ever-changing “C” in CGMP.
The process proactively ensures that updates to regulatory agency guidance and regulations and evolving agency expectations as well as technical standards are systematically discovered and evaluated for impact to the firm’s quality system and that the necessary actions are taken to ensure the quality standards and systems remain current.
Keeping corporate standards current is important, but represents only basic compliance. For a robust quality system, other external information should be monitored, evaluated, and communicated. The accumulation of information is easily repurposed into GMP training, and further leveraged by putting it into a comprehensive knowledge management platform. This online training will demonstrate the importance of these elements, how they fit together, how to design the system, and how your firm can benefit.
Faculty - Mr.Jerry Chapman
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.