Process Validation for Packaging of Pharmaceuticals and Medical Devices
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This 2-day intensive program has been specially 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
Extensive knowledge of validation is not required.
Description
This course provides a structured approach to validation
practices, to ensure that the packaging of a drug, medical
device or allied product, conforms to its predetermined
specification. Targets include consistent quality to the
consumer, compliance with regulatory requirements, safety,
cost effectiveness, financial and other company benefits.
The need to translate 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. Examples such as a push-through-pack
machine, a packaging line, cleaning and sterile pack integrity
are included.
Specific tasks and requirements of the various functional
groups involved are covered in depth. Vendor/supplier
assessment, FAT and auditing are crucial and will be outlined.
Group exercises will provides practice in developing skills to
prevent or eliminate failures and rejects in processing.
Participants will select from a group of six relevant validation
topics for presentation and discussion.