Friday May 18, 2012 Friday May 18, 2012
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Environmental monitoring of controlled and classified environments is required to maintain compliance per EMA/FDA/Health Canada requirements.
When a new or remodeled controlled and/or classified manufacturing area is established, a plan is required to determine the manufacturing surfaces and airborne testing (ISO 14644). This testing may extend to the media, personnel, incubators, refrigerators, development of SOPs, etc.
The program will involve the DQ, IQ, OQ and PQ of the site and all of its equipment. Since the facility’s environmental and utility plan must be established and in compliance prior to the initiation of manufacturing, an extensive Gantt chart is a prerequisite to assure activities are completed in a predetermined order and that the earliest possible date for initiation of production may be met.
Any equipment that is required to initiate monitoring along with their DQ, IQ, OQ, PQ and their SOPs need to be in place. The same is required for autoclaves, incubators and refrigerators that must be temperature mapped to include the setting up of alarms and “offsets”.
The necessary regulatory documents also need to be in place and translated into the various SOPs. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document, USP (current version), etc.
The objective of this live and interactive IPA Canada web training is to explore and define the necessary elements in the development of an Environmental Plan for a controlled/classified environment and assist in assuring that your organization is maintaining itself within a GMP compliance framework.
Those who will benefit from this seminar include Regulatory Compliance, Risk Management, Quality Assurance, Microbiology, Quality Control, Manufacturing and Facilities professionals who are developing a new controlled/classified environment, revamping/remodeling an existing environment or maintaining an environment on a day to day basis.
Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.
Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland.
As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.
Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. He was responsible for the microbiology, environmental monitoring and analytical chemistry for Phase 1, 2, 3 and commercial products aseptically filled/lyophilized.
In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.
COMPANY PROFILE: Barry A. Friedman, Ph.D., LLC
Barry A. Friedman, Ph.D., LLC was founded in 2007 to provide consultation and training to the pharmaceutical/biopharmaceutical and medical device community, specializing in regulatory compliance, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology, and providing a wealth of information to clients.
Dr. Friedman is a frequent seminar speaker in the GMP areas of GLP/GMP, risk management, internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi and IPA (Canada). He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA. He is the 2009 PDA recipient of the James Agalloco award for excellence in teaching.
Follow Dr. Friedman BLOG: http://barryafriedmanphdllc.wordpress.com/
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.
