Course Description

Documentation Management and Control

October 2-3, 2018
New Brunswick, NJ

Course Offering 181002NJ1866
Course ID 1866

In-Person Course

Who Should Attend?
This basic introductory course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries. The course will also benefit individuals in a variety of functions
such as:

  • QA/QC
  • Regulatory
  • Auditing
  • Production
  • R&D
  • Product Development
  • Toxicology
  • Vendors/Suppliers
  • Clinical Research
  • CRO’s

RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
Regulations such as Good Manufacturing Practice for drugs and medical devices, Good Laboratory Practice, Good Clinical Practice, as well as quality system standards like ISO 9000, require that various types of documentation be in place. These regulations, however, do not provide any guidance to the industry on how to set up and manage documentation systems. It is, therefore, left up to companies to design and set up their own internal documentation systems.

This introductory course provides hands-on methodology and techniques on how to identify systems that require documentary coverage. It also covers the design, implementation and management of such documentation systems to ensure continuous compliance. The course also addresses FDA’s concerns regarding data integrity.

Types of documentation addressed include: quality manuals, policy manuals, standard operating procedures, work instructions, forms, records, etc. The course also addresses aspects of 21 CFR Part 11—Electronic Records and Signatures.

The program consists of lectures, discussions and case studies.

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.

Venue Information
New Brunswick, NJ Area
Hotel Information sent with
course confirmation package