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GMP Compliance for Quality Control and Contract Laboratories

ComplianceOnline

Tuesday, December 5, 2017 at 8:30 AM - Wednesday, December 6, 2017 at 4:30 PM (CET)

GMP Compliance for Quality Control and Contract Laborat...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird offer)
Registrations till September 20, 2017 - $1899
Ended $1,899.00 $76.92
Seminar One Registration Dec 5, 2017 $2,099.00 $82.92
Seminar One Registration (USD) (With 2 Nights Stay) Dec 5, 2017 $2,099.00 $82.92

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Event Details

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 understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.

Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.

 

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 warning letters.

 

Who Should Attend:

This seminar will be beneficial to the following personnel in FDA regulated laboratories:

  • Analysts and lab managers
  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • IT professionals
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants& teachers

 

For Registrationhttp://www.complianceonline.com/gmp-compliance-for-quality-control-and-contract-laboratories-seminar-training-80112SEM-prdsm?channel=eventbrite


Note: Use coupon code  REFERRAL10  and get 10% off on registration.

Have questions about GMP Compliance for Quality Control and Contract Laboratories? Contact ComplianceOnline

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When & Where


Amsterdam

Amsterdam
Netherlands

Tuesday, December 5, 2017 at 8:30 AM - Wednesday, December 6, 2017 at 4:30 PM (CET)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

  Contact the Organizer
GMP Compliance for Quality Control and Contract Laboratories
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