Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Attendees from the sterile medical device industry have also benefited from this training.

Although, the course emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals, these subjects are presented in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking.

Please be aware that this course is designed to address aseptic filling common to biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes.

Who Should Attend

This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

Paul Larocque

Paul Larocque

Specialties: Manufacturing

Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological and medical device consultancy which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past twelve years as a consultant, and previously in industry, Paul's focus was FDA compliance matters.

Previously, Paul held executive positions related to sterile products with Pfizer, SmithKline/Allergan and Eldan Pharmaceuticals. He also headed the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. In addition, he chaired the industry committee that negotiated the sterile products chapter of GMP regulations at Health Canada.

He received his Bachelor of Science degree in Chemistry from the University of Ottawa. Mr. Larocque is a Chartered Chemist in Ontario, a Member of the Chemical Institute of Canada and was chosen for the Governor General's Study Group.

He was named a Fellow of The Organization for Professionals in Regulatory Affairs in Europe and has served on several trade association boards or committees; including a Chairmanship on the committee which negotiated Canadian GMP Guidelines. Mr. Larocque has twice been elected Chair of the Canadian Association of Professionals in Regulatory Affairs.

Publications:

• Larocque, Paul: Regulatory Rapporteur, page 29, January 2012, The International Journal for Professionals in Regulatory Affairs, Vol. 9, No. 1.
• Larocque, Paul: Regulatory Rapporteur, page 28, October 2012, The International Journal for Professionals in Regulatory Affairs, Vol. 9, No. 10.
• Larocque, Paul: Aspects on the harmonisation agenda, Regulatory Rapporteur, page 27, February 2013, The International Journal for Professionals in Regulatory Affairs, Vol. 10, No. 2.