Course Description

GMP Audits: Basic Tools and Techniques

Online On Demand

Course Offering 1808902OL2819A
Course ID 2819

In-Person Course

Who Should Attend?
Newly assigned auditors or those who expect to be involved in auditing in the near future will find this introductory training very beneficial. It can also be of interest to those who need a refresher on this important subject matter. Professionals in the functions described below will also find the topic of interest:
  • Quality Assurance
  • Purchasing
  • Documentation Management
  • Quality Control
  • Production
  • Laboratory
  • Packaging
  • Regulatory Compliance
  • Vendors/suppliers

Course Description
This 90-minute, accredited, introductory online training covers the main steps to be taken when setting up and implementing a GMP audit program in the pharmaceutical, medical device and related industries. It outlines the requirements identified in FDA regulations, ICH guidances and ISO 13485-2016 standard regarding the need for an audit function. It covers various areas of concern including laboratory and manufacturing operations, risk management and data integrity issues.

For in-depth training on this topic, consider the CfPA 3-day,
in-person training:

Conducting Effective Quality Audits
Course ID #1681

Course Director
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.