CGMP: Packaging Controls

Michael C Redmond

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$349


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The good manufacturing practice in packaging controls program describes cGMP requirements for the control of packaging materials and operations. Students will explore the reasons that labeling problems still constitute one of the most common reasons contributing to product recalls. The objectives of this course are to teach procedures for label control, line clearance, verification procedures, and procedures for reconciliation. The curriculum covers an introduction, printed material control, line clearance and set up, on-line controls, reconciliation, and a summary of all the above stated material.

COURSE OBJECTIVES:

·Label control procedures.

·Reconciliation procedures.

·On-line verification procedures.

· Line clearance procedures.

COURSE OUTLINE:

INTRODUCTION

1. Introduction

2. Poor packaging controls

3. What you will learn

4. Outcomes

PRINTED MATTER CONTROL

5. Printing operation

6. Quality control

7. Delivery to manufacturer

8. Receiving inspection

9. Label storage and coding

10. Issue from the label store

11. What did you learn?

LINE CLEARANCE AND SETUP

12. Setup summary

13. Review I

14. Review II

15. ON-LINE CONTROLS

16. On-line controls I

17. On-line controls II

18. Run charts

19. Control charts

20. Monitor this process

21. Review

RECONCILIATION

22. Reconciliation

23. Reconciliation limits

24. An example

25. A labeling example to do

26. The solution

27. SUMMARY

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



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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