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Establishment of a Risk-Based Environmental Monitoring Program - June

Jun 22 - Jun 22, 2017 |
Jun 22, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Limited information and guidance currently exists on how to conduct environmental monitoring (EM) risk assessments. Current regulatory requirements prescribe that sample site locations and sampling frequencies must be risk-based with documented rationales, but there is little to no guidance on how to perform these types of risk assessments. There is currently large interest in the industry for guidance on this topic.

This course will present information on the establishment of a risk-based EM program. It will cover both the establishment of new as well as reassessment of current EM programs to bring them into compliance with industry standards. This course will review routine EM program requirements and EM program qualification requirements. Instruction will be given on the use of risk tools for determination of microbial contamination sources in production environments and processes, and on the use of EM risk assessment tools.

There will be small group breakouts for completion of EM risk assessments: Fishbone Diagrams, FMEAs and HACCPs. The goal of this course is to understand the tools available for conducting EM risk assessments and how to properly utilize them to create risk-based EM programs.

Who Should Attend

Environmental Monitoring Samplers, Microbiologists, Microbiology Department Managers and Supervisors, Validation Technicians and Managers, and Quality Assurance staff responsible for risk assessments reviews will benefit from this course.

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

  • Discuss global requirements for the establishment risk-based environmental monitoring programs
  • Utilize assessment tools are available for environmental monitoring risk analysis
  • Perform environmental monitoring risk assessments utilizing risk tools (Fishbone, FMEA, HACCP)
  • Establish risk-based environmental monitoring programs at your company

Standard

Member

On or Before May 5, 2017
$1,699

After May 5, 2017
$1,899

Nonmember

On or Before May 5, 2017
$2,051

After May 5, 2017
$2,279


Government/Health Authority/Academic

$1,139

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

Marsha Hardiman, Senior Consultant, Concordia ValSource

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 #347 | ACPE #0116-0000-14-070-L04-P | 0.6 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 6 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 6 PDHs.

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