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 : 5th December 2017 to 6th December 2017

Place : Gambia The, Amsterdam

Website :https://www.eventbrite.com/e/gmp-compliance-for-quality-control-and-contract-laboratories-com-a-tickets-36892648906?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 Amsterdam,Gambia The on date 2017-12-06

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Deadline for abstracts/proposals : 4th December 2017

Keynote Speakers : Dr. Ludwig Huber Chief Advisor - Global FDA Compliance, Labcompliance Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences. He served as a team member of P

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 :Amsterdam, Netherlands

Check the event website for more details.