$694 – $2,397

1 day seminar GMP’s in practice: quality systems, common sense compliance,...

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Hilton Garden Inn Washington DC /

U.S. Capitol 1225 First Street, NE

Washington, DC 20002

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Description

1 day seminar GMP’s in practice: quality systems, common sense compliance, and application. is on December 07 location: Washington D.C

Duration: 1 day (7 contact hours)

DESCRIPTION

Description: 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.

Why should you attend:

Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.

Meanwhile, companies consistently claim their employees are trained and they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax —operators are told in just a few hours about the contents of hundreds of pages of SOPs.

As a result, these reportedly trained professionals can’t possibly have learned the material and have little recollection of procedures or knowledge of how to handle deviations, resulting in defects, recalls and other product problems that cost companies untold billions of dollars.

Unfortunately, GMP trainers are often expected to do just that — create a training course, get everyone’s signature on the training sign-in sheet and hope that people will work differently. For training to be truly effective, organizations must move from a training environment to a learning environment.

Contents:

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

WHO WILL BENEFIT

• Compliance officers
• Consultants/service providers
• Engineering and design control teams
• Executive management
• Managers
• Manufacturing directors and supervisors
• Procedure writers
• Pharmaceutical and cGMP auditors
• QA/QC personnel
• R&D staff
• CAPA specialists
• Training personnel
• Instructional designers and technologists


Instructor Profile

Ginette Collazo, Ph.D, President, Ginette M. Collazo, Inc.

GINETTE COLLAZO, PH.D.
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.

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Hilton Garden Inn Washington DC /

U.S. Capitol 1225 First Street, NE

Washington, DC 20002

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