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CfPA-The Center for Professional Advancement, New Brunswick, NJ
December 1-2, 2016
Who Should Attend?
This course is designed to introduce cGMPs for Medical Devices to individuals who are in a new position needing to familiarize themselves with requirements of the cGMP, have been away for a time and need a re-introduction, or individuals who are coming from other manufacturing industries and need information on FDA/ISO 13485 requirements for the manufacturing of Medical Devices.
It will be especially valuable to professionals in the following areas:
• Quality Assurance
• Engineering
• Quality Control
• Research and Development
• Production
• Software
• Maintenance
• Process Design and Development Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Daniel Aisen; Senior Compliance Auditor, mdi Consulting, Inc. |
Daniel Aisen is a consultant to the Food, Medical Device, and Clinical Research community as an Senior Compliance Auditor for mdi Consulting, Inc. out of Great Neck, NY. His experience spans over a period of over 40 years in the field of regulatory inspections including the US Navy (Retired) and US Food and Drug Administration (retired). Having conducted thousands of inspections, he brings a unique prospective to understanding the various roles and responsibilities of individuals, understanding the cause/effect relationship, and adding a common sense approach to fulfill the requirements of the regulations without undue burden upon the resources of the company.
Mr. Aisen has vast international experience in the inspection arena conducting over 110 inspections, audits, and classes in 23 countries throughout Asia (including India, Japan, China, Taiwan, and Thailand), Europe, North and Central America and Australia.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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jmorbit@cfpa.com
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The course will address cGMPs recognized in the medical device manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. It will will provide guidance and instruction governing the basic manufacturing practices and quality control procedures including: Incoming receipt inspections, segregation practices for non-conformance items, manufacturing flow, supporting manufacturing documentation, clean room vs. environmental control room requirements and practices, clean room validation requirements, training requirements, maintenance and calibration of equipment, warehousing, quality control requirements, and supplier qualifications.
The course will not include statistical analysis and sampling procedures.