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Course ID:
1789

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Process Validation for Packaging of Pharmaceuticals and Medical Devices

This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.

This course is available as a client site course. Please click here for more information.

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 Management
  • 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 essentials of validation are highlighted using practical examples as; a push-through-pack machine, a packaging line, cleaning and sterile pack integrity.

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.

Group exercises and discussions will offer participants practice to develop skills to prevent or eliminate faults, failures and rejects in processing.

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