Manufacturing of Potent Drugs
Includes an Overview of the ISPE Containment Community of Practice (COP)

ISPE CEUs*: 0.2

 Purchase from ISPE's Online Store

Speakers

Lesley Burgess, Bsc, Msc, Dip OH, Industrial Hygiene Consultants
Nigel Hamilton, Sanofi-Aventis
Bruce D. Naumann, Ph.D., DABT, Merck & Co.
Edward V. Sargent, MPH, Ph.D., DABT, Merck & Co.
Andy Walsh, Hoffmann-LaRoche
Paul Wreglesworth, AstraZeneca
Julian Wilkins, PharmaConsult US, Inc.
Stephanie Wilkins, PharmaConsult US, Inc.

Description

This online seminar will bring delegates up to date on the current regulatory thinking with regards to multi-product facilities and "potent" compounds. Delegates will also learn what steps are being taken to move the industry to a science and risk-based approach to determining when dedicated facilites are needed.

This presentation was given to the FDA on January 25, 2006 to address using a risk management approach based on the ICH Q9 document to assist in the decisions for employing risk control strategies, specifically when dealing with High Hazard Compounds. This presentation was developed to show the FDA that multi-product facilites can be safely employed even when producing highly hazardous compounds (aka potent compounds).

Topics Covered

• Risk Management/Risk Assessment
• Exposure Assessment
• Controlling Risk
• Cleaning

Learning Objectives

At the end of this Online Seminar, participants will be able to:

• Define Hazard, Exposure and Risk and how they are related
• Understand how an ADI (Acceptable Daily Limit) can be used to develop limits that can be used to evaluate how to control risk
• Compare the differences between Industrial Hygiene (IH) needs and cGMP needs
• View a logic diagram that provides a tool for making risk-based decisions
• Define how to set cleaning limits for cleaning validation to support the control methods employed

Who Should Attend

• Professionals with containment, cross-containment, and product segregation concerns, including personnel who handle materials with an occupational exposure limit below 50 micrograms for APIs, oral solid dosage, inhalation, and parenteral applications.

You Can Also Get Involved in the ISPE Containment COP

The ISPE Containment Community of Practice (COP) provides a focus for those professionals in the Engineering, Environmental Health & Safety, Occupational Toxicology, Operations, Quality, Regulatory, and Validation areas as well as the vendors who provide containment systems, integration and processing, where the issues of safety for patients, operators and environment are key issues. The COP will seek to influence regulators and professionals worldwide and advance quality, cost, and safety issues.

One of the best ways to get involved is to join one of the Containment COP subcommittees that include: Membership - to recruit and retain members of the COP; Hot Topics – to set and execute hot topic issues for the Listserv e-discussion forums; Education – to provide content, execution and quality review for the ISPE educational offerings; COP Relationships – to liaise with other COP’s to ensure consistency of message; and Tech Docs – to liaise with the Tech Docs committees.

Contact ISPE's Business Initiatives Department at businessinitiatives@ispe.org to get involved, or if you have comments and suggestions.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an email confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.