| |
|
|
|
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
August 11, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This course is intended for all personnel involved with the following areas of pharmaceutical and medical device sterile facilities:
• Design
• Construction
• Validation
• Operation
• Monitoring
Other personnel who will find this course of interest:
• Design Engineers
• Test Contractors
• Equipment Manufacturers
• QA/QC
• Regulatory Affairs
• Production
• Maintenance Description
This 3-part online training series reviews the current state of the technology associated with pharmaceutical, medical device, active pharmaceutical ingredient, medical component, R&D, and microbiological clean rooms.
Each session of the series may be taken individually. However, for the maximum training benefit, you are encouraged to attend the complete three part presentation.Register for all 3 parts and save $150!
This 90-minute accredited training will focus on developing procedures for monitoring the various classifications of clean rooms as well as how to address a monitoring specification failure. It will also address procedure for personnel activity in the clean rooms as well as gowning practice and training. Tips on how to effectively audit the clean room associated activities will also be covered.
Module 1:
• Room classifications (EU,US,ISO)
• Typical activities carried out in the various classifications
• Monitoring programs for each room classification
Module 2:
• Personnel Training
– Gowning
– Clean room behavior
Module 3:
• Typical deviations
• Investigating and correcting deviations
• Auditing tips
Question and Answer Session
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA - The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
William G. Marshall, President, William G. Marshall and Associates
William G. Marshall is President of William G. Marshall and Associates. He has over twenty years experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational pharmaceutical corporations as well as start-up ventures. He has been the Director of a major reference laboratory, and has been active in clean room design and validation. In the last five years, he has acted as a third party in several consent decrees.
Mr. Marshall is currently a consultant to the worldwide drug and device industry as well as to the FDA. He lectures worldwide in GMP related issues including Clean Room Technology and Sterilization. In the past 18 months, he has been involved in 10 Pre-Approval Inspections that include the first aseptic processed injectables from India, the first ever drugs from Turkey, and APIs from China, that were all approved for introduction to the US market. He has a Master's Degree in Biology from Georgetown University, Washington, DC.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
sberg@cfpa.com
|
|
|
|
|
|
|
|
|