Course Description

Effective Documentation Practices for GXP Compliance

Online On Demand

Course Offering 1811901OL2818A
Course ID 2818

In-Person Course

Who Should Attend?
This overview, introductory course will benefit professionals in a variety of functions in the pharmaceutical, medical device, biotech and related industries who are responsible for the writing, implementation or management of various types of documents. These functions include:
  • Documentation writers/managers
  • Regulatory
  • Audit
  • QA/QC
  • Training
  • Middle /Upper management
  • Manufacturing
  • Laboratory operations
  • Pre-clinical operations

Course Description
This 90 minute accredited online course offers a road map for participants in setting up and implementing a documentation management system in their companies. The course details the documentation requirements as identified in FDA GXP Regulations, ICH Guidances and ISO 13485- 2016. It describes the role of documentation and presents examples of the main documentation requirements in various stages of activities. The online training concludes with the transition from a manual environment to an electronic environment and with a few examples of FDA warning letters identifying noncompliance.

For in-depth training on this topic, consider the CfPA 2-day,
in-person training:

Documentation Management and Control
Course ID #1866

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.