GMP Compliance for Quality Control and Contract Laboratories for FDA and EMA compliance

Sept. 5, 2013 - PRLog -- Why to attend:

Quality control laboratories are considered high risk because after testing and approval pharmaceutical drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC and related contract 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 up-to-date requirements and implementation

Areas Covered in the Seminar:

* FDA and international regulations and guidelines
* Current inspection practices and most frequently found deviations
* Major differences between GMP and non GMP laboratories
* Quality system requirements
* Compliance along the laboratory workflow and most critical steps
* Developing a laboratory compliance master plan
* The importance of a compliance team
* Developing a project plan for step-by-step implementation
* Writing GMP compliant laboratory SOPs
* Correct sampling and sample handling
* Qalification and maintenance of equipment
* Validation of analytical methods
* Handling out-of-specification situations
* Preparation for FDA inspections
* Recommendations for cost-effective operation

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* PowerPoint Presentation
* Script
* Laboratory compliance master plan
* Laboratory compliance: Step by Step SOPs
* SOP: Handling OOS results
* SOP: Conducting Management Reviews
* SOP: Generation and Maintenance of Laboratory SOPs
* SOP: Validation of Analytical Methods
* SOP: Training of Laboratory Personnel
* SOP: Auditing Analytical Laboratories
* Worksheets/Checklists/Examples: Laboratory Audits

Date:  November 21, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* Pharmaceutical and API industry
* Contract laboratories
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultants


Weblink:  http://www.labcompliance.com/seminars/audio/326/default.aspx

Category: Pharmaceutical, GMP, API Manufactuer, FDA, Training

Presenter: Dr. Ludwig Huber

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the  US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA