CfPA-The Center for Professional Advancement, New Brunswick, NJ
June 11-12, 2015
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.
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Invited Speakers:
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Mervyn J. Frederick; Former Head of the Packaging Development Group, MSD-Organon (former N.V. Organon) The Netherlands
Mervyn J. Frederick, following early retirement is Former Head of the Packaging Development Group of N.V. Organon, Currently MSD-Organon in The Netherlands. He is responsible for the evaluation, prescribing and advising on packages and materials with respect to pharmaceutical, regulatory, production, marketing and consumer requirements. He contributes to the development of unique presentations and devices for the company’s products world wide. He holds a number of patents.
He has a Higher National Diploma in Chemistry (GB) and his earlier experience included development of pharmaceutical technology, analytical procedures and formulations at the Department of Pharmaceutical Sciences of the Royal Pharmaceutical Society of Great Britain, in London and Edinburgh.
Mr. Frederick is a Fellow of the Institute of Packaging, UK and is an internationally recognized consultant for the preparation, and presentation of professional training and lectures in Packaging, Validation, Material Distribution (Logistics), European Union Laws on Packaging and Packaging Waste. He serves as examiner for various established institutions and has been active in committee work for the Netherlands Normalization Institute, German Industrial Standards and International Standards Organization.
Mervyn Frederick is dedicated to promoting packaging professionalism and the improvement of packaging standards for the industry and consumer.
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