The Center for Professional Advancement, New Brunswick, NJ
August 6-8, 2007
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.
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