| |
|
|
|
The Center for Professional Advancement, 90 Minute Accredited Online Training
June 2, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This introductory online presentation will benefit professionals in the pharmaceutical, medical device and related industries who are responsible for GMP compliance issues. The course will be of great interest to newly assigned auditors or those who expect to be involved in auditing in the near future. It can also be used as a refresher course for more experienced auditors.
The material presented will be very beneficial to professionals in the following areas:
• Management responsible for audit function
• QA/QC
• Regulatory
• Vendors and suppliers to these industries
• Laboratory
• Production
• Packaging
Description
Auditing is a major management tool to ensure compliance with regulations and standards. The need for GMP system-based audits is a worldwide requirement at all stages, starting with active pharmaceutical ingredient (API) , bulk pharmaceuticals, finished pharmaceuticals, medical device, biologics etc. This 90-minute accredited training course provides an introduction to the major regulations and standards requiring the existence of an audit function in companies. It details the beginning stages for setting up a system-based audit program and concludes with a few examples of check points during drug and device system-based audits.
Module 1: Requirements for system-based audit programs as identified in:
• QSR – Quality System Regulation for medical device
• FDA Guidance for Pharmaceutical Quality Systems
• Q7A – GMP for Active Pharmaceutical Ingredients
• ICH Q10 – Pharmaceutical Quality System
• Quality System Standards – ISO 9000 and 13485
Module 2: Getting started
• Audit classification
• Audit manual/procedures
• The audit cycle
• Audit master plan
Module 3: Is your company in compliance?
• Following the ten commandments of cGMP
• Check points during drug GMP system-based audits
• Check points during device GMP system-based audits
• Examples of Warning Letters
Question and Answer Session
|
|
|
|
|
|
|
|
Organized by:
|
|
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 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. 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 (CfPA).
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
salbers@cfpa.com
|
|
|
|
|
|
|
|
|