GMP Pharma Certification

This course has been designed to help you to prepare for ASQ Certified CGMP Professional. The course covers briefly all the required areas of the body of knowledge, as specified by ASQ. This certification will enhance your quality career.

Course Benefits

Students will be able to articulate U.S. laws, drug regulations and global regulatory framework and all information related to CGMP requirements including those impacting all processes and products.

At the end of this course, students will be prepared to:

1. Relate the structure of US laws and global regulatory requirements pertaining to pharmaceuticals and their implementation

2. Highlight history of drug regulations

3. Explain the global regulatory framework

4. Identify the FDA Centers and their role in drug regulation

5. Interpret frequently used regulations and guidance

6. Adapt mutual recognition agreements

7. Define and describe various types of regulatory inspections

8. Determine the various enforcement actions

9. Implement regulatory agency reporting

10. Compare differences between a site master file (SMF) and drug master file (DMF)

11. Summarize the Pharmaceutical Quality System and the associated requirements

12. Evaluate and audit Quality Management Systems (QMS)

13. Assess Quality Unit (site) Management

14. Determine Risk Management using PFMEA and DFMEA

15. Assess training needs and personnel qualification

16. Prepare for change control and change management

17. Conduct investigations and implement corrective and preventive actions (CAPA)

18. Organize audits and self-inspections

19. Implement document and records management

20. Define the difference between product quality complaints and adverse event reports

21. Examine product trend requirements

22. Implement supplier and contractor quality management

23. Deduce the requirements for Laboratory Systems

24. Conduct laboratory investigations of aberrant results

25. Document instrument control and record-keeping practices for requirements

26. Design stability programs and manage all controls to the standard including installation and servicing

27. Articulate Supply Chain Management and the requirements for:

• Supplier identification

• Supplier relationship management

• Supplier requirements

• Supplier logistics

28. Explain open market innovation

29. Demonstrate that sterilization process always require validation

30. Identify the requirements for filling, packaging and labeling

31. Illustrate quality by design concepts, design space

32. Utilize process analytical technology (PAT) tools

33. Scale up and transfer phase-appropriate GMP requirements

Who Should Attend?

• Professionals who are looking to obtain the ASQ CGMP Certification.

Prerequisites:

• See ASQ’s certification requirements. Technology or Equipment Required Access to use of computer and internet. All courses are instructor-driven and provided via online or in-person. Certification Requirements (Learning Outcomes) To attain certificate of completion, attendees must pass the examination, earn a passing grade (70% score) in course assessments, and meet all prescribed professional requirements of attendance, participation, and learning objectives. Any homework given is required to be completed before course ends.

Topics Covered:

Body of Knowledge

• Regulatory Framework and Guidance
• Quality Management System
• Documents and Management
• Instrument Control and Record Keeping
• Infrastructure: Facilities, Utilities and Equipment
• Materials and Supply Chain Management
• Sterile and Nonsterile Manufacturing Systems
• Product Development and Technology Transfer

Please Note: Price includes materials, certificate of attendance. The material includes binder, book, and CD with questions.