Thursday February 23, 2012 Thursday February 23, 2012
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A review of recent Form FDA 483 Observations and Warning Letters often provide very "telling" information regarding where the FDA is having their Investigators focus when they conduct an audit.
Form FDA Form 483s are not typically available without the use of the government's Freedom of Information (FOI) or a private provider of similar services. However, when the FDA desires to inform the public about a particular recent audit, they may independently release the Form FDA 483 without any prerequisite of a request. These documents may be released in as few as a few days or after several years following the conclusion of the audit. In addition, FDA's Electronic Reading Room provides an "early warning" through their publishing efforts. Often, the rapid release of these documents suggests that the FDA is dissatisfied with the on-going interaction with a Client and provides this information to all interested parties to demonstrate their concerns.
In a review of these Form FDA 483s, the various Observations are often a result of a misuse of FDA Guidance for Industry documents where the FDA's Client either executes the Guidance insufficiently or proceeds beyond what is required. In addition, these Observations may also be referenced by AAMI documents where the Client did not follow the documents' protocols and the result was the release of contaminated product. A number of Case Studies will be presented that incorporate the corresponding FDA Guidance for Industry as well as AAMI reference.
The objective of this live and interactive IPA Canada webinar is to explore selected recent Form FDA 483s and Warning Letters which were obtained during calendar year 2011. These Observations may provide guidance for your personnel regarding organizational requirements and training to assure that they understand the level of microbiological training and experience that exist and may be required within your organization.
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 CASE STUDY I -- Aseptic Processing and the Misuse of the FDA Guidance for Industry Sterile Aseptic Processing CASE STUDY II -- Non-Sterile Product and "Specified" Microorganisms CASE STUDY III -- Sterile Product and the Misuse of AAMI Cobalt Irradiation Guidance |
| 2:00 PM | Break |
| 2:10 PM | CASE STUDY IV -- Aseptic Processing within a Phase 1/Phase 2 Contract Manufacturing Operation |
| 3:00 PM | Live Questions and Answers |
*Please note that all times are Eastern Daylight Savings 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.
