GMP Pharma Certification
- All levels
- 18 and older
- $2,395
- Earn 23,950 reward points
- Price Lock Guarantee
- 28 Lord Road, , Marlborough, MA
- 45 hours over 5 sessions
Thankfully we have 4 other Business Classes for you to choose from. Check our top choices below or see all classes for more options.
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
American Management Association
Discover how to become an outstanding leader by developing your emotional intelligence skills in this course offered by American Management Association. Gain valuable insights and techniques to enhance your overall effectiveness and create a healthy and productive workplace culture. Learn how to inspire and motivate your organization's workforce to reach new heights of achievement.
May 20th
9am–4:30pm EDT
Meets 3 Times
American Management Association
Discover the secrets to maximizing productivity and achieving extraordinary results in the workplace with this seminar provided by the American Management Association. Learn how to make clear decisions, manage your attention and energy, and create a personalized system for achieving high-impact goals. Take control of your productivity and unlock your full potential.
Jun 17th
9am–4:30pm EDT
Meets 2 Times
American Management Association
Unleash the power to negotiate, influence, and persuade with persuasive skills training that focuses on key elements of influencing others when there is a lack of authority. Enhance your ability to win respect, build relationships, and cultivate cooperation to achieve career success. Join this course to master the art of getting results without authority.
Jun 20th
9am–4:30pm EDT
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.
Secure your booking now and we'll match any price drop within 48 hours across all booking platforms, ensuring you never miss out on savings!
Maximize your savings with every purchase. Unlock rewards on every transaction, ensuring you get the most value out of your experience!
Enjoy hassle-free transactions without worrying about additional charges. With us, what you see is what you pay - no surprises!
Discover a curated selection of courses handpicked by experts in the field. Dive into quality content that suits your learning needs and interests!
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.