Developing an Environmental Monitoring Program
PDA #102 | ACPE #116-000-07-102-L04-P | 1.8 CEUs
Location: PDA TRI Training Facility, Bethesda, Maryland
Date: May 4-6, 2009
Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.
Registration Fee
| Member |
Nonmember* |
Government/ Health Authority** |
Academic** |
Student |
| $3,495 |
$3,895 |
$2,000 |
$2,000 |
N/A |
|
All rates in US dollars.
* Registration fee includes a one-year PDA membership. No additional payment is required.
** Must be a PDA member to receive this rate. In order to take advantage of this discounted rate, you must register by faxing or mailing a completed copy of your registration form to PDA.
|
Course Description
Held in an interactive cleanroom setting, this new course will define the key components that must be part of a successful Environmental Monitoring program: Aseptic Gowning plus Non-Viable and Viable Environmental Monitoring. The Viable Monitoring portion will include surface sampling, contact plates and swab sampling, and air sampling using active air samplers and settling plates. The Non-Viable portion will include particulate testing using local Particle Counting units. A rationale for selecting testing sites for different class areas will also be discussed, along with how to effectively interpret the data collected.
Who Should Attend
Quality Control - Managers, Directors and Supervisors
Quality Assurance - Managers, Directors and Supervisors
Manufacturing - Managers, Directors and Supervisors
Learning Objectives
Upon completion of this course, participants will be able to:
- Describe the Regulatory Requirements related to their environmental monitoring program.
- Identify key elements of an Environmental Monitoring Program
- Explain the importance of Personnel Monitoring as it relates to environmental monitoring in a classified environment
- Determine critical sampling Locations, appropriate sampling Methodology and Frequency
- Determine the necessity of Anaerobic and Selective Media Monitoring
- Define proper Incubation schemes and Identification procedures
- Determine appropriate alert and Action Level Limits for different area classifications
- Explain the importance of, and determine an appropriate method of trending Environmental monitoring data over a given period of time
- Identify criteria for and procedure for initiating Non-Conformance Investigations
Faculty
Barry A. Friedman, Barry A. Friedman, PhD., LLC
Location
The course will be held at the PDA Training and Research Institute:
PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814
USA
Contact
For more information, please contact:
James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
Email: wamsley@pda.org