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Fundamentals of an Environmental Monitoring Program - June

Jun 20 - Jun 21, 2017 |
Jun 21, 2017 |
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 clean room. 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

Standard

Member

On or Before May 5, 2017
$2,419

After May 5, 2017
$2,699

Nonmember

On or Before May 5, 2017
$2,915

After May 5, 2017
$3,239


Government/Health Authority/Academic

$1,619

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by May 22, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

Location

The course will be held at:

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

Recommended Hotel

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

Contact

For more information, please contact:

Kimberly McIntire
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

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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