SeerPharma Pty Ltd :: DISCover web-based training

UK | Singapore | Korea

GMP7: Production Controls

Description: Builds on the Contamination Control module. Controls for starting materials, dispensing and processing; and what actions to take when confronted with non-conforming materials, products and processes.

Price: $209 (AUD)

(Australian customers, please add GST.)

Note: We use 128-bit SSL security encryption on all webpages where private information is taken.

Terms and conditions

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 labelling
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
36. An example II

CONCLUSION
37. Summary
38. Summary II

COURSE OBJECTIVES

Students completing this course should be able to:

List ways to maintain the quality of starting materials
List some dispensing and processing controls
State the GMP requirements for handling manufacturing deviations
Define the word "yield" and give an example of where and why it is used

Home

Training Programs

Upcoming Training

Compliance Consulting

DISCover e-Learning

Modules available

SOPtrain

Quality Management Software

Clinical Trials Software

SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.