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Laboratory Control Basics

  October 21, 2013  
CfPA - The Center for Professional Advancement, FREE Lunch & Learn Webinar
October 29, 2013 at 12:00 –12:30 p.m. (ET)

Who Should Attend
The emphasis of this Lunch and Learn session is directed toward Laboratory personnel.

The regulatory requirements for Laboratory Controls in the drug industry are identified in 21CFR211, Subpart I Laboratory Controls. However, technology and quality systems have evolved considerably since that regulation was written in 1978 and the practices in the laboratory and the expectations of the regulators have also evolved. In order to be compliant in the current environment, laboratory, managers, supervisors and analysts must be aware of the current industry practice, Quality System concepts and processes and regulatory expectations. This Lunch and Learn session is intended to provide of few examples of situations in which the laboratory is not meeting the regulatory expectations, an analysis of the deficiencies and suggested actions to bring the laboratory in compliance. It will benefit laboratory managers, supervisors and analysts in Quality Control and Development.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: 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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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