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The Center for Professional Advancement, New Brunswick, NJ
June 25-27, 2008
Who Should Attend
This course is designed for those who are responsible for performing laboratory work or managing a laboratory in conformance to current good manufacturing practice (cGMP) for pharmaceutical products. It will be of special interest to:- QC Chemists
- Developmental Chemists
- Microbiologists
- Laboratory Supervisors
- Managers
- QA Record Reviewers and QA Auditors
Description
Laboratory Control has been the largest identifiable area of cGMP observations of non-compliance during FDA inspections for the past decade. Recently the FDA changed its inspectional technique to focus on systems. The emphasis of this seminar will be the Laboratory Control System identified in the FDA Systems Inspection Program and the relationship of the Laboratory Control System components to the cGMPs (21CFR210 and 211) and FDA and ICH guidance documents. Discussions include examples of investigational observations. Discussions, workshops and course notes include assessment checklists.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. John G. (Jerry) Lanese; President, The Lanese Group, Inc.
Dr. John G. (Jerry) Lanese received a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. He moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. His past company affiliations include Stiefel Laboratories, Bristol Laboratories, Carter Wallace, Inc. and Marion Merrell Dow.
Since 1994 Dr. Lanese has been an independent consultant in the area of cGMP compliance and has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree; electronic firms and other manufacturing organizations.
Dr. Lanese lectures throughout the world on a variety of topics related to GMPs, APIs, laboratory operations, calibration, computer system validation and electronic documentation, change control, deviations and annual product reviews. He also provides customized training for his clients. The article, “Training in the Laboratory” , authored by Dr. Lanese was voted best article for 2005 by the Journal of GXP Compliance.
Dr. Lanese is a member of the Editorial Board of the Journal of Validation Technology. He has been active in the Kansas Award for Excellence program for the past ten years and has served as Examiner, Lead Examiner and Judge. Dr. Lanese is also a member of American Society for Quality, AOAC and the Institute for Management Consultants. He is a Certified Management Consultant (CMC). He is also president of Kansas City Ragtime Revelry, an organization with a mission of promoting ragtime music.
Dr. Alan J. Smith; Pharmaceutical and Technology Consultant
Dr. Alan J. Smith is a consultant specializing in pharmaceutical quality and technology. He was formerly the Corporate Director of Quality Affairs for the Whitehall Laboratories Division of American Home Products Corporation (now Wyeth) following a career with the Ayerst Division. He received his B.Sc. and Ph.D degrees from the University of London in the UK and also studied Business Administration at the Wharton School of the University of Pennsylvania. He has been President of the Montreal Pharmaceutical Discussion Group and Chairman of numerous pharmaceutical conferences. Dr. Smith is a member of the Editorial Advisory Board of the journal “Pharmaceutical Technology”. He was the recipient of the 1998 WorldPharm Award for services to the pharmaceutical industry.
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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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info@cfpa.com
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