Setting Up and Implementing Supplier Audits

January 03, 2019

CfPA-The Center for Professional Advancement, Online Live
March 13, 2019 at 11:00 a.m.–12:00 p.m. (ET)

Who Should Attend?
This accredited training will be of value to those professionals in the pharmaceutical, medical device and related industries responsible for or involved in any interaction with suppliers, including those in the following functions:
  • Top Management
  • Audit
  • QA/QC
  • R&D
  • Manufacturing
  • Regulatory Affairs
  • Laboratories
  • Purchasing
  • Technical Services
  • Legal
  • Validation
  • Documentation Management

Course Description

The 60-minute, accredited online training will present a brief overview of the outsourcing process in the FDA regulated industries with emphasis on risk management techniques and the importance of quality agreements. Details about steps needed to be taken by companies to set up and implement a supplier audit program will be discussed.

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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