Process Validation for Packaging of Pharmaceuticals and Medical Devices Training Course :

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&rsquo;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 course covers the essentials of validation and gives details of validating; a push-through-pack machine, packaging line, cleaning and sterile pack integrity.<br><br> 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.<br><br> Exercises in small groups and discussions will offer participants practice to develop skills to prevent or eliminate faults, failures and rejects in processing.