Friday May 18, 2012 Friday May 18, 2012
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Aseptic Processing experienced a reawakening in 2011 with the two Form FDA 483s issued by the FDA to Ben Venue Laboratories (BLV) and to Formatech. BVL, which involved not only the FDA, but also the MHRA, French and Canadian authorities demonstrates how various regulatory bodies can coordinate their activities to achieve both recalls as well as ultimately the closing of a facility without the issuing of a Warning Letter or seizure.
Corrective actions have now been initiated by BVL with an anticipated resumption of the South Facilities by the end of the First Quarter 2012. Formatech, however, received a Warning Letter following the receipt of a Form FDA 483 and subsequently has shutdown -- perhaps on a permanent basis.
The FDA and EMA require that any product that can be terminally sterilized be managed in that fashion. However, almost all large molecules and some small molecules can only be sterilized by aseptic processes, i.e., membrane filtration.
With membrane filtration, it is essential to establish acceptable levels of microbiological contamination to ensure both product safety and compliance. Meeting sterility claims for Phase 1, 2, 3 and commercial products in a timely and effective manner is important to avoiding costly delays. In addition, since aseptic processes are associated with endotoxin control, it too, must be managed to acceptable levels.
A variety of variables can impact sterility assurance and the accompanying endotoxin level. Many of these issues are demonstrated within the BVL two Form FDA 483 which form a "poster child" for aseptic processing. The total of 58 Observations form the bases for issues that include the personnel, process, equipment, components, sterilization, depyrogenation, facilitates and utilities that impact the management and processing of the ultimate products. Issues that impacted Formatech included the monitoring of environmental areas with a lack of comprehensive investigations when mold and bacteria were identified, adequacy of disinfection procedures, and failure of a batch or any of its components to meet specifications.
The objective of this live and interactive IPA Canada webinar is to explore and provide suggested solutions to facilitate aseptic management and processing of sterile products with the minimum associated risk using the BVL and Formatech Observations as the bases for Case Studies.
The webinar participants will learn the following:
Webinar Outline and time breakdown:
| Time* | Activity |
| 12:45 PM | Log In Period |
| 1:00 PM | Introduction |
| 1:10 PM | Definitions Fundamental Principles and Skills of Aseptic Processing Issues using BVL and Formatech as Case Studies and how the proper usage of the Aseptic Processing Guidance can assist Determining the Process Controls |
| 2:00 PM | Break |
| 2:10 PM | Issues Associated with Media Fill Simulations The Critical Factors Required to Maintain Compliance The Requirement for Six Month Media Fill Requalifications Form FDA 483 Observations and Warning Letters Applicable to Aseptic Processing |
| 3:00 PM | Live Questions and Answers |
*Please note that all times are Eastern Time
The following individuals or disciplines will benefit from attending this Webinar
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.
