It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check.
This fact is the primary reason for which regulatory agencies such as the FDA, EMA and many others place the highest emphasis and priority on inspections of QC laboratories. This is also one of the main reasons for which a huge number of QC related 483’s and Warning Letters get issued to companies that have problems with their implementation, despite the existence of cGMP regulations for a long time.
Helping to understand and imbibe GMP
A complete understanding of GMP for Quality Control and contact laboratories will be offered at a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. Dr. Ludwig Huber, Chief Advisor – Global FDA compliance at Agilent Technologies, will be the Director at this seminar.
To gain the benefit of this learning, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900698SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
The regulatory background and guidelines
At this highly interactive two-day seminar, Dr. Huber will offer to participants the regulatory background and guidelines needed for all critical areas of GMP compliance. He will update them with the latest requirements of this compliance document, which will help them understand and implement these.
As a result of the learning gained at this two-day course, participants will be able to:
- Learn about the regulatory background and GMP requirements for quality control and contract laboratories
- Understand and be able to explain their 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 their organization on GMP requirements
- Learn how to avoid and/or respond to the FDA inspectional observations and Warning Letters.
A practical session
In addition, the Director will also be providing participants with templates and examples with which they can develop inspection-ready documentation. Another of the highlights of this session is that practical examples and interactive exercises will be sprinkled into and between the presentations, with half of the duration of the seminar being dedicated for practical sessions.
Taking the interactive element a step further, Dr. Huber will arrange participants into small groups for the purpose of discussing case studies and prepare the answers using prepared fill-in templates. Yet another bonus of this session is that after the course, Dr. Huber will make a large variety of tools such as SOPs, validation examples and checklists readily available on a dedicated website so that those who have attended this seminar can use them to easily implement what they have learned from the course.