This GMP webinar training will cover the design and implementation of a GMP surveillance program to ensure awareness of and compliance with ever-changing US and international GMP manufacturing regulations, guidance, inspection findings, trends, and related information, and how the process can be used to create GMP training and made even more valuable across the organization in the context of a quality knowledge management platform.
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.
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
Speaker
Jerry ChapmanCourse Provider
Jerry Chapman,
