Course Description

All aspects of a Quality Control Microbial Identification Program for the 21st Century will be presented and discussed. Participants will have an opportunity to design an efficient microbial identification process flow for their quality control laboratory. Other courses are presented by microbial identification system vendors, this one is by users with over forty years of experience in the industry.

TOTAL PACKAGE in a two day training to support a robust microbial identification program:

• Microbial Identification systems for now and in the future
• An understanding of the principles and methodologies of phenotypic and genotypic systems
• Strengths and Weaknesses of identification systems observed by actual users
• How primary methods enhance the identification program
• Support and justify microbial identification systems for purchase, including Return on Investment
• Identification instrument qualification
• Contract laboratories—choosing and using them
• An understanding of current regulatory and compendia expectations for identifications, including USP<1113>
• Points to consider and case studies for objectionable microorganism risk assessments

Who Should Attend

• Quality Assurance: Managers, Supervisors
• Quality Control: Managers, Supervisors

Learning Objectives

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

• Develop a robust microbial identification program.
• Comprehend and compare the principles and results of current and under development microbial identification methodologies, including phenotypic and genotypic systems.
• Describe how primary methods support an identification program.
• Discuss the strengths and weaknesses of the microbial identification systems.
• Support and justify microbial identification systems for purchase.
• Know how to qualify a microbial identification instrument.
• Implement an efficient microbial identification process flow using concepts learned in the course.
• Develop a safe and acceptable procedure for shipping and transporting isolates.
• Choose and work with a contract laboratory.
• Discuss regulatory and compendia expectations for microbial identification of isolates.
• Use risk assessment principles and tools to determine risk of isolates and evaluate impact of objectionable organisms

Faculty

Mary Griffin, M.S., SM (NRCM), Biopharmaceutical/Pharmaceutical Microbiologist, MG Quality Microbiology Consulting, LLC and Dona Reber, SM (NCRM), Microbiology and Aseptic Support, Pfizer

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 March 29, 2010	$1,435	$1,705	$950	$1,050
Price After March 29, 2010	$1,595	$1,895	$950	$1,050

All rates in US dollars.

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