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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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July 08, 2013 |
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CfPA - The Center for Professional Advancement, East Brunswick, NJ
November 18-19, 2013
Who Should Attend
This course is designed for those who are responsible for performing laboratory work or managing a laboratory in conformance to current standards for good testing laboratory management, with a focus on FDA regulated industries. It will be of special interest to:
• Quality Control Analysts
• Microbiologists
• Managers
• Developmental Chemists
• Laboratory Supervisors
• Quality Assurance Record
Reviewers and Auditors Description
Laboratory Control has been the largest identifiable area of cGMP observations of non-compliance during FDA inspections for a number of years. In 2001 the FDA changed its inspectional technique to focus on systems. More recently the FDA has been emphasizing Quality Systems. The emphasis of this course will be the Laboratory Control System identified in ISO 17025 and the FDA Systems Inspection Program and the relationship of the Laboratory Control System components to the cGMPs (21CFR 210 and 211) and other guidance documents. Discussions include examples of investigational observations.
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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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Dr. Jerry Lanese; Pharmaceutical Quality & Technology Consultant
Dr. Jerry Lanese, an International Pharmaceutical Industry Consultant, has a Ph.D. in Analytical Chemistry from the University of Michigan. He began his career teaching Analytical Chemistry at the college level. He moved to industry where he has gained more than 30 years of quality control, quality assurance and analytical research experience in the pharmaceutical industry. He has worked in large and small pharmaceutical firms managing Analytical Research & Development and QA & QC functions. Dr. Lanese was the quality representative on the team that started manufacturing operations in Puerto Rico for a major pharmaceutical firm. For the past 17 years, he has been a consultant in the drug and medical device industries focusing on laboratory activities, performing quality assessments and helping both small and large firms to achieve a higher level of compliance. Dr. Lanese has been part of several teams working with firms under consent decree. Jerry is a member of the Editorial Advisory Boards of the Journal of GXP Compliance and is the co-author of a column, “GXP Talk” that appears in each issue of this Journal.
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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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sberg@cfpa.com
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