Containment Technology Forum: Case Studies, Concepts, and Compliance (E03)

2-3 June
1.2 CEUs
2.0 Industrial Hygiene
CM Points
Approval #: 08-072		 Working Agenda
Current as of 1 May 2008
Download Working Agenda  PDF, 37 KB 

Containment is no longer just an occupational health issue! It now plays a major role in compliance to ensure product safety. If you process multiple products in your facility, or desire to, this seminar addresses immediate issues you face.

Contract Management Organizations will benefit directly from the concepts and case studies presented. Regulators worldwide know that CMOs routinely handle multiple products in their facilities so the perceived risk of cross contamination is higher.

Regulations are currently being revised to allow manufacturers more flexibility to minimize the risk of cross contamination. However, to capitalize on that greater latitude, manufacturers now need to more thoroughly assess their risks of cross contamination and develop control strategies to meet today’s regulatory scrutiny and requirements.

Case studies reinforce techniques presented and show application in real life situations. Interactive workshops enhance understanding of important issues.

The end of seminar question and answer session with regulatory representatives may be the best part of the seminar, and well worth the cost of the event. It is a rare opportunity to receive direct advice from regulators on your specific containment concerns.

Risk-MaPP will be discussed as a tool. The cornerstone of the new ISPE Baseline® Guide Risk-MaPP is to set safe limits for cross contamination and to apply appropriate containment technology. This Guide is also reviewed in depth at a Conference seminar on Thursday, 5 June.

Give your company a competitive edge in the marketplace by getting the latest on containment straight from the original source — ISPE.

Containment COP General Meeting - ISPE’s Containment COP Steering Committee will host its second general meeting and networking reception on Tuesday, 3 June, from 17:30 to 19:30 following the Containment Technology Forum. Delegates attending the containment seminars are invited to attend this two hour meeting for updates on the community’s activities, refreshments at the reception, and to join in roundtable discussions. Pre-registration is required. Sponsorships are available by contacting Dave Hall, dhall@ispe.org, or Karen Newhouse, knewhouse@ispe.org.

How You Will Benefit

At the conclusion of this session, participants will be able to:

  • Describe solutions for containment challenges, and how to handle Beta-Lactam production;
  • Understand current regulatory climate for compounds of concern, and highly hazardous compounds;
  • Verify need for new analytical and sampling methods;
  • Use Risk-MaPP/ICH Q9 approach to determine containment technology to reduce cross contamination; and
  • Understand critical issues for a client with CMO auditing.

Who Should Attend

Engineers, occupational toxicologists, industrial hygienists, environmental scientists, quality and operations personnel

Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Containment (Containment), Disposables (Disposable), Heating, Ventilation, and Air Conditioning (HVAC), Project Management (PM), Oral Solid Dosages (OSD-In development), and Sterile Products Processing (SPP)

Related Technical Documents
Available from ISPE - www.ISPE.org/publications  

Baseline® Guide Series

Seminar Leaders

Speakers

Event Sponsors