Description
<strong>Course Schedule - April 29-May 1, 2009</strong><br/><br/>This course provides a structured approach to validation
practices, to ensure the packaging of a drug, medical device
or allied product, conforms to its predetermined specification.
Targets are: consistent quality to the consumer, compliance
with regulatory requirements, safety, cost effectiveness, long
term financial and other benefits to the company.<br><br>
The need to translate customer/user requirements to
measurable specifications, followed by controlled processing is
explained. Emphasis is on practical ways of implementing
validation, using protocols, SOP's, planning, statistics, process
controls and other tools. The Validation-Master Plan/Protocol,
protocols, templates for IQ, OQ and PQ, and change controls
are all detailed with text.<br><br>
The essentials of validation are highlighted using practical
examples as; a push-through-pack machine, a packaging line,
cleaning and sterile pack integrity.<br><br>
Specific tasks and requirements of the various functional
groups involved are covered in depth. Regulations and the
types of validation will be discussed. Vendor/supplier
assessment, FAT and auditing are crucial and will be outlined.<br><br>
Group exercises and discussions will offer participants practice
to develop skills to prevent or eliminate faults, failures and
rejects in processing.
