CGMP: Production Controls


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This program offers an overview of good manufacturing practice, with a comprehensive emphasis on production controls. The program builds on GMP06, the contamination control course. The course will describe and define starting material controls, dispensing controls, processing controls, process monitoring, and handling deviations. Most importantly, the course will address the proper actions to be taken when confronted with materials that are nonconforming. The course objectives cover how to perform reconciliation and yield calculations, the purpose of clearance procedures, and why strict manufacturing controls are needed.

COURSE OBJECTIVES:

·The need for strict manufacturing controls.

·The purpose of room clearance procedures.

·How to perform yield and reconciliation calculations.

COURSE OUTLINE:

INTRODUCTION
1. Introduction
2. Production controls
3. What you will learn
4. Outcomes


STARTING MATERIAL CONTROL
5. Starting material
6. Receiving
7. Receiving II
8. Sampling and testing
9. Status labeling
10. Storage
11. Storage II
12. Issue


DISPENSING CONTROL
13. Dispensing controls
14. Room clearance
15. Setup
16. Dispensing
17. Dispensing II
18. Clean-up
19. Review
20. A dispensing step


PROCESSING CONTROL
21. Processing
22. Room clearance
23. Room clearance II
24. Formulation controls
25. In-process checks
26. In-process checks II
27. Batch records
28. Batch records II
29. Clean-up


PROCESS MONITORING
30. Process monitoring
31. Exercise


HANDLING DEVIATIONS
32. Handling deviations
33. Handling deviations II
YIELD
34. Yield
35. An example

Webinar Events
Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.


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