Fundamentals of an Environmental Monitoring Program

Location: PDA Training and Research Institute, Bethesda, Maryland
Date: September 16-17, 2014 
Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This course will identify microbiological and particulate control concepts and principles as they relate to the manufacture of pharmaceutical products, and other designated controlled environments.

The course will discuss, in detail, controlled environmental test methods, with a focus is microbiological control. The most stringent concepts of environmental monitoring as it relates to facility control and compliance are presented for sterile product manufacturing, but these concepts can also be used as an aid to design a program for non-sterile product manufacture.

Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the clean room and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.

Who Should Attend

Quality Control/Quality Assurance - Technicians, Microbiologists, Specialists, Managers and Supervisors
Validation/Engineering - Technicians, Specialists, Managers and Supervisors
Manufacturing - Specialists, Managers and Supervisors

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

  • Apply current regulatory guidance to your environmental monitoring program
  • Implement improved environmental monitoring procedures
  • Compare and contrast new and existing environmental monitoring equipment.
  • Outline how to best utilize current environmental monitoring definitions
  • Define key environmental monitoring concepts
Standard
Government / Health Authority / Academic
Member Non-Member Member Non-Member
Price on or before August 1, 2014 $2,350 $2,595 $1,500 $1,600
Price after August 1, 2014 $2,595 $2,895 $1,500 $1,600

All rates in US dollars.

Class Schedule

All lab 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 8:00 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 PDA Training and Research Institute:

PDA Training and Research Institute
4350 East West Highway, Suite 150
Bethesda, MD 20814

Contact

For more information, please contact:

James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137

Email: wamsley@pda.org

ACPE The 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. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #102 | ACPE #0116-0000-12-102-L04-P | 1.2 CEUs
Type of Activity: Application

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