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Supplier Audits

  October 18, 2018  
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
September 10-11, 2019

Who Should Attend?
This intensive, practical two-day course will be of value to those professionals in the pharmaceutical, medical device and related industries who are responsible for or involved in any interaction with suppliers, including those working in:

  • Management 
  • Laboratories
  • Auditing 
  • Purchasing
  • QA/QC 
  • Procurement
  • R&D 
  • Legal
  • Manufacturing 
  • Validation
  • Regulatory Affairs 
  • Documentation Management

Course Description
Outsourcing represents a critical and complex process involving many parties and covering many geographical areas. This process has become a global phenomenon.

This practical course will outline details of the outsourcing process in the FDA regulated industries with emphasis on the critical aspects of monitoring and preserving the integrity of the supply chain. The importance and use of risk management techniques will be presented.

The course will present the latest industry approaches and practices in setting up and implementing supplier audits and will discuss concrete steps to be taken by companies all over the world, when implementing this program. Case studies and group hands-on workshops will give participants an opportunity to brainstorm and create real life documents.
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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