Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness and Response

Location: Bethesda North Marriott Hotel in Bethesda, Maryland
Date: November 12, 2013
Duration: 1 Day
Time: 8:30 a.m. - 4:00 p.m.

There is the potential for mammalian cell lines used for the production of protein therapeutics and vaccines to be contaminated by a range of adventitious agents, including viruses. Contamination of large-scale cell culture processes with adventitious agents, although a rare event, has been reported in the literature and at various scientific conferences. Such contaminations can be extraordinarily disruptive to GMP operations and potential product supply, and therefore have patient impact. The purpose of this course is to describe principles and measures that can be taken to reduce the risk of contamination by viruses and to provide guidance to help prepare for and respond effectively should such an event occur.

The course will provide the necessary information and tools to enable companies and participants to (1) understand and implement best practices to reduce the risk of viral contamination during the manufacture of biologicals, and (2) position course participants to be able to establish strategies to quickly, and strategically respond to such an event in order to contain spread, efficiently initiate and conduct an investigation, implement corrective action, minimize disruption to production, and help ensure minimal impact on company operations and supply of product to patients.

Who Should Attend

Personnel responsible for adventitious agent control, manufacturing control, raw material acquisition, investigation of viral / adventitious agent contamination, and strategic planning for minimizing disruption of manufacturing operations and product supply. These would include process and analytical development scientists, manufacturing scientists and directors, virologists / microbiologists, QA and QC personnel, directors of regulatory affairs, VP Manufacturing, VP Process Development, VP Quality and related personnel.

Upon completion of this course, you will be able to:

  • Discuss sources of viral contamination and appropriate steps that can be implemented to mitigate risk from these sources
  • Identify areas of vulnerability to introduction of viral contaminants in production, and how to implement measures to reduce the risk of a process breach
  • Discuss the value, need and content of a proactive strategic plan for responding to a viral contamination during production
  • Describe the components of a good strategic plan for responding to a contamination
  • Proactively prepare a strategic action plan tailored to specific biopharmaceutical processes
  • Identify a list of potential corrective actions to consider following a viral contamination
  • Identify a list of potential actions that can be taken to prevent viral contaminations
Michael E. Wiebe, PhD, President, Quantum Consulting, LLC
Standard
Government / Health Authority / Academic
Member Non-Member Member Non-Member
Price on or before September 26, 2013
$895 $1,165 $600 $700
Price After September 26, 2013
$995 $1,295 $600 $700

All rates in US dollars.

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Location

The course will be held at the Marriott Bethesda North Hotel and Conference Center:

Marriott Bethesda North Hotel and Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Phone: (301) 822-9200

Contact

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

For registration inquiries please call:
+1 (301) 656-5900 ext. 115

Description: ACPEThe PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms.

PDA #232 | ACPE #0116-0000-13-232-L04-P | 0.6 CEUs
Type of Activity: Application
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