One Day GMP's in Practice Course: Quality Systems, Common Sense Compliance, and Application (Tampa, FL, United States - December 7, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "GMP's in Practice: Quality Systems, Common Sense Compliance, and Application" conference to their offering.

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.

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.

Who Should Attend:

- 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

Agenda:

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

For more information about this conference visit http://www.researchandmarkets.com/research/txmnsq/gmps_in

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Production and Quality Management

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Production and Quality Management