| |
|
|
|
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
May 14, 2015 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This overview online presentation will benefit professionals in various 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:
• Pre-clinical operations
• Clinical operations
• Laboratory operations
• Manufacturing processes
• QA/QC
• Auditing
• Regulatory
• Documentation writers/managers
• Training Course Description
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA-The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
| Renée B. Galkin, Quality Management Consultant |
Renée B. Galkin is a quality management consultant with over twenty years of 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).
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:
|
|
sberg@cfpa.com
|
|
|
|
|
|
|
|
|
This 90-minute accredited online course presents an overview of the main types of documents required in FDA regulations and guidances, in ICH guidelines and in ISO 9000. Based on industry best practices, this presentation will discuss ways to classify documents and will clarify the distinction between controlled and non-controlled documents. The transition from manual systems to electronic systems and the impact of 21 CFR Part 11 upon documentation will conclude the course. Please note that details about the management and control of documents, and documentation systems are discussed in other technical public courses offered by CfPA.