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

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.

Continuing Education Credits

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.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before July 9, 2010	$3,145	$3,415	$2,000	$2,100
Price After July 9, 2010	$3,495	$3,795	$2,000	$2,100

All rates in US dollars.

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