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.
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:
o Learn about
the regulatory background and GMP requirements for quality control and contract
laboratories
o Understand
and be able to explain their company's quality plan or laboratory compliance
master plan
o Understand
the difference between GMP and non-GMP laboratories
o Learn how to
develop inspection ready documentation
o Be able to
train others in their organization on GMP requirements
o 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.