DESCRIPTION Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees

Date : 20th November 2017 to 21st November 2017

Place : Singapore, Singapore

Website :https://www.eventbrite.com/e/gmp-compliance-for-quality-control-and-contract-laboratories-com-tickets-38830403783?aff=NDT

Contact Person: Paula Edwards

Description:

DESCRIPTION Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees

DESCRIPTION Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees will be held in Singapore,Singapore on date 2017-11-21

---

Deadline for abstracts/proposals : 17th November 2017

Keynote Speakers : Dr. Ludwig Huber Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare." He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This includes seminars, workshops an

Conference Highlights :Learning Objectives: -Learn about the regulatory background and GMP requirements for quality control and contract laboratories. -Understand and be able to explain your company’s quality plan or laboratory compliance master plan. -Understand the difference between GMP and non-GMP laboratories. -Learn how to develop inspection ready documentation. -Be able to train others in your organization on GMP requirements. -Learn how to avoid and/or respond to the FDA inspectional observations and

Venue :Singapore

Check the event website for more details.