GMP Pharma Certification
- All levels
- 18 and older
- $2,395
- 28 Lord Road, , Marlborough, MA
- 45 hours over 5 sessions
Thankfully we have 7 other Business Classes for you to choose from. Check our top choices below or see all classes for more options.
American Management Association
Learn the practical skills of emotional intelligence for effective workplace relationships and productivity in this seminar at the American Management Association. Enhance your awareness, connect with others, manage stress, engage in healthy conflict and collaboration, and exhibit resilience and optimism for personal and business success.
Apr 10th
9am–4:30pm EDT
Meets 2 Times
American Management Association
Develop the essential management skills that will set you apart and elevate your team to new levels of greatness at the American Management Association. Gain expertise in motivation, delegation, coaching, communication, and leadership to become a successful and effective new manager.
Apr 25th
9am–4:30pm EDT
Meets 2 Times
American Management Association
Unleash Your Leadership Potential and Take Charge of Your Career with Expert Training in Effective Leadership at the American Management Association.
Apr 25th
9am–4:30pm EDT
Meets 2 Times
American Management Association
Unlock your managerial potential and become an effective leader with the essential skills and tools taught in this powerful workshop. Don't miss out on the opportunity to transform your management style and unleash your team's full potential.
Apr 29th
9am–4:30pm EDT
Meets 2 Times
Six Sigma Development Solutions, Inc. @ 100 Boardman Street, Boston, MA & Virtually Online
The Lean Six Sigma Black Belt certification course is full of games, videos, and other active learning. We will be using simulations to learn the importance of data and statistics when solving a process problem. At the end of the course, the Master Black Belt Instructor will give you the tools to complete your Six Sigma Black Belt Certification project quickly and effectively.
Apr 15th
8am–4:30pm EDT
Meets 5 Times
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?
Prerequisites:
Topics Covered:
Body of Knowledge
Please Note: Price includes materials, certificate of attendance. The material includes binder, book, and CD with questions.
REFUND POLICY: (AS PER M.G.L. CHAPTER 255, SECTION 13K)
People who viewed this class also viewed the following classes
Get quick answers from CourseHorse and past students.
Quality & Productivity Solutions, Inc. is an international firm dedicated to providing practical and effective consulting and training to achieve client objectives. Whether it’s improvement in process, product, service, or overall performance, exceptional results are our business. We partner with...
Read more about Quality & Productivity Solutions, Inc
This school has been carefully vetted by CourseHorse and is a verified Boston educator.
Quality & Productivity Solutions, Inc
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752 Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
Booking this class for a group? Find great private group events
Or see all Professional Group Events
Explore group events and team building activities ranging from cooking, art, escape rooms, trivia, and more.
More in Professional
Get special date and rate options for your group. Submit the form below and we'll get back to you within 2 business hours with pricing and availability.