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2020 workshop GMP’s in practice: quality systems, common sense compliance, and application
Date
Link to Website
Organizer
Location
Ticket Price: Seminar One Registration - $1,295.00 Special Group Discount Register for Four attendees - $ 3885
Course “2020 workshop GMP’s in practice: quality systems, common sense compliance, and application“ has been Pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.
"Each attendee will receive 1-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion
Each attendee will receive 1-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS.
This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Design: Content based, experiential (real site specific examples), 483’s evaluation and Warning Letter discussions. Case studies.
Areas Covered
1. Management and Supervision Responsibilities
2. Quality Risk Management
3. Knowledge Management and Organizational Learning
4. Quality Management and Quality Systems
5. Product and Process Monitoring
6. Discrepancy Observation and Investigation
7. Complaints
8. Qualification and Validation
Who will Benefit
• Compliance officers
• Consultants/service providers
• Engineering and design control teams
• Executive management
• Managers
• Manufacturing directors and supervisors
• Procedure writers
Agenda
Course Outline:
(8:30 AM - 4:30 PM)
Registration Process - (8:30 am till 8:45 am)
1. Management and Supervision Responsibilities
2. Quality Risk Management
3. Knowledge Management and Organizational Learning
4. Quality Management and Quality Systems
5. Product and Process Monitoring
6. Discrepancy Observation and Investigation
7. Complaints
8. Qualification and Validation
9. Learning, Training and Performance
10. Documents, Records and Recordkeeping
11. Change Management
12. Corrective Action and Preventive Action (CAPA)
13. Materials and Packaging Components
14. Vendors, Third Parties, and Outsourcing
15. Sampling
16. Equipment Cleaning
17. Sanitation
18. Facilities and Utility Systems
19. Warehousing and Storage
20. Distribution Practices
21. Maintenance, Repair, and Calibration
22. Materials Receiving
23. Equipment
24. Manufacturing and Packaging
25. Identity Control
26. Label Control
27. Batch Release
28. In-process Controls
29. Clothing and Personal Hygiene
Speaker Details
Ginette M. CollazoPh.D, President, Ginette M. Collazo, Inc.
Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.