Process Validation for Packaging of Pharmaceuticals and Medical Devices
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Who Should Attend
This program is prepared for personnel in pharmaceuticals,
medical devices, personal care products, cosmetics,
toiletries, and the veterinary medicines industries.
It will benefit those employed in packaging in:-
Development
- Technology
- Processing
- QA/QC
- Auditing
- Engineering
- Purchasing
- Marketing
- Regulatory Affairs
- Project Leading
- Outsourcing
- Suppliers
Extensive knowledge of validation is not required.
Description
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.
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.
The course covers the essentials of validation and gives
details of validating; a push-through-pack machine, packaging
line, cleaning and sterile pack integrity.
Specific tasks and requirements of the various functional
groups involved are covered in depth. Regulations are given
special attention and prospective, concurrent and retrospective
validation will be discussed critically. Vendor/supplier
assessment and auditing are crucial and will be outlined.
Exercises in small groups and discussions will offer
participants practice to develop skills to prevent or eliminate
faults, failures and rejects in processing.
Other Courses of Interest
Design Control and Product Validation
Oct 06 2008, New Brunswick, NJ
Drug Product Stability and Shelf-Life
Dec 10 2008, Burlingame, CA
Drug Product Stability and Shelf-Life
Mar 02 2009, Boca Raton, FL
IQ, OQ, PQ
Nov 11 2008, Burlingame, CA
IQ, OQ, PQ
Jan 21 2009, Boca Raton, FL
Packaging of Pharmaceuticals
Preparation, Packaging and Labeling of Clinical Trial Materials
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