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Parenteral Drug Association Connecting People, Science and Regulation ®

Fundamentals of an Environmental Monitoring Program - Option 1

Apr 10 - Apr 11, 2019 |
Apr 11, 2019 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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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 on 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.

This laboratory course will give you the opportunity to work hands-on with environmental monitoring equipment and media. You'll have the opportunity to work with the instructors to develop a surface and air environmental monitoring program for PDA's cleanroom. You will utilize the information presented in the lectures to determine appropriate sampling sites and methods based on area classification, activities performed and surface type.

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

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

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



On or Before February 22, 2019

After February 22, 2019


On or Before February 22, 2019

After February 22, 2019

Government/Health Authority/Academic*


*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by March 9, 2019, no fee will be charged. After March 9, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by March 9, 2019, a full refund will be given minus a $200 fee. After March 9, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to Phone messages are not accepted.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Kimberly McIntire
Manager, Education
Tel: +1 (301) 656-5900 x103

Dona Reber, Global Quality Operations, Microbiology and Aseptic Support, Pfizer
Dona has over 30 years of academic and industrial experience in microbiology laboratories and manufacturing support. In her current role in Global Quality Operations, Microbiology and Aseptic Support at Pfizer, she is responsible for assessing aseptic processing facilities, leading investigations, writing policies and aseptic processing training.

She is also a member of three PDA Task Forces authoring and revising upcoming PDA Technical Reports. She has multiple publications covering topics, including environmental monitoring, microbial identification and microbiological risk assessments. She co-authored the PDA/DHI technical book Microbial Identifications: The Keys to a Successful Program, October 2012.

Marc Glogovsky, S.M. (NRCM), Global Business Manager - SMA Division, Veltek Associates, Inc.
Marc has over 15 years experience in aseptic operations, rapid microbiology and environmental monitoring. He currently manages VAI's Environmental Monitoring business, and is responsible for global sales, support operations and product management.

He is a founding member of the PDA Mycoplasma Task Force, and has multiple presentations and publications covering topics related to mycoplasma, aseptic processing, sterility testing, rapid microbiology and environmental monitoring.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #102 | ACPE #0116-0000-16-033-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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