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Auditing for GMP Compliance

  January 12, 2018  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
7-8 June 2018

Who Should Attend?
This overview, practical course is designed for those auditors who have recently been involved or expect to be involved in internal or external GMP audits

The program will benefit individuals in the pharmaceutical, medical device and related industries like diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations.

The course can be of interest to top management responsible for GMP audit programs in their companies as well as to professionals in a variety of functions such as:

  • QA/QC
  • Laboratories
  • R& D
  • Production
  • Regulatory Compliance
  • Packaging
  • Engineering
  • Documentation Management

Course Description
GMP regulations worldwide as well as FDA and ICH guidances require that companies have in place an internal and supplier quality audit program.

Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance.

The course will deal primarily with auditing tools and techniques needed when conducting effective internal and external GMP audits It will consist of lectures, interactive discussions and hands on case studies.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries.

Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association. Throughout her career Ms. Galkin held both domestic and international assignments.

Ms. Galkin has an MBA in Business Management from New York University, an MA in Education and Science from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). She is also a Certified Quality Auditor.

As a consultant, Ms. Galkin has been providing training and consulting advice to pharmaceutical and medical device companies in the United States and Europe in areas related to consent decrees, pre-approval and regular FDA inspections, audit programs, quality systems requirements, documentation systems management, validation, supplier selection and management.

She also directs several technical courses offered by the Center for Professional Advancement. Participants at her courses enjoy and appreciate her interactive and personal teaching style which keeps the audience alert and constantly involved.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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