Documentation Management and Control

December 05, 2016

CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 3-4, 2017

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. 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 interactive workshops with classroom presentations.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Course Director
	Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, GMP training, documentation systems management, strategic planning and organizational development.

Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies – Wyeth Pharmaceuticals, Inc. (now Pfizer) and Science Management Corporation (a multinational consulting firm). Throughout her career she had both domestic and international assignments.

Ms. Galkin holds an MBA in Business Management from New York University, an MA in Education 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). As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. She also directs several technical courses offered by The Center for Professional Advancement.

Deadline for Abstracts:

N/A

Registration:

Please click here for registration information.

E-mail:

Jmorbit@cfpa.com

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