Course Description

Documentation Management and Control

February 11-12, 2020
Edison, NJ

Course Offering 200211NJ1866
Course ID 1866

In-Person Course

Who Should Attend?
This introductory course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries, such as medical device, diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations. 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

Although an introductory course, for more experienced professionals this training can confirm that their existing documentation practices are fully in compliance with the latest regulatory requirements. Also, the course can serve as a useful primer for more advanced related topics such as internal and supplier audits.

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. Class size is limited to ensure individual interaction with the instructor. Participants are encouraged to discuss their own needs and challenges regarding documentation.

“Course covered topics that I needed to go back to my management to make needed changes in [our] process. Speaker [Renee Galkin] is tremendously experienced in her field. I worked more on the audit class.“
S.S., Manager, Document Control, Prolong Pharmaceuticals, LLC

“The instructor [Renee Galkin] is very knowledgeable easy to follow good and well organized.” A.B., Chemist, Ashland

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
ExitCertified (MicroTek partner facility)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
Phone: 800-207-9620 (for directions and parking info only)

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.

Directions: Visit the Hotel Venue topic on our FAQ page.