A Holistic Approach to External GMP Surveillance, GMP Training and Quality Knowledge Management

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.

Learning Objectives:

• Understand external GMP surveillance and influence and why it is important
• Learn a process model for performing surveillance and influence
• Understand the importance of the human element
• Learn how to package the same communication output for individuals at different organization levels and interests
• Understand how the process model feeds into GMP training
• Learn what quality knowledge management (QKM) is
• Recognize the key elements of a QKM system
• Learn how the QKM system is used and how it benefits the company

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• QA managers and personnel
• Regulatory affairs managers and personnel
• GMP auditors
• GMP audit preparation teams
• Consultants
• Pharmaceutical development
• Contract manufacturers

Jerry Chapman
GMP Quality Expert, YourEncore

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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