Risk Management and The New General Chapter, USP<60>, Burkholderia cepacia

Why Should You Attend:

Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62> and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found. Nevertheless, it is still classified as an “objectional”, but not “specified” microorganism.

The method of transmission through direct contact with other individuals includes the shaking of hands and even body perspiration. Although B. cepacia does not appear to survive on completely dry surfaces for more than one week, it can survive for many months in water. B. cepacia can use other routes of transmission including contact with hard surfaces. Perhaps most important to note is this microbe’s ability to remain viable under harsh conditions (e.g., organic solvents, antiseptics, low nutrients, etc.) for many months. Given the robust nature of the organism, it is important to consider the relatively high patient risk when this microorganism is present in manufacturing equipment, components, or the process water used in manufacturing pharmaceutical products.

Areas Covered in the Webinar:

• A review of the pertinent history of B. cepacia.
• Extensive review of the process involved in the isolation and identification of B. cepacia.
• Explore the “new” recommended medium for propagation of this microorganism
• Learn why USP<60> does not provide a sufficient identification (genus/species) within 16S rRNA identification platforms
• Use of B. cepacia within USP<1111> as a potential monograph addition.
• Experience what Companies have encountered with Recalls, Form FDA 483s and Warning Letter examples.
• Case studies of Warning Letters with B. cepacia

Who Will Benefit:

• Manufacturing
• Validation
• Quality Control
• Quality Assurance
• Microbiology
• Research/Development
• Project Management

Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology.

From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.

In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, 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, TungstenShield (PharmaWebinars), IPA (Canada), Executive Conference Corp, Compliance On-Line and Pharmig (UK).

Dr. Friedman maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms to assist with finding the appropriate Warning Letter and FDA 483. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

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