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Parenteral Drug Association Connecting People, Science and Regulation ®

Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process

Oct 19 - Oct 19, 2018 |
Oct 19, 2018 |
Bethesda North Marriott Hotel & Conference Center | North Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes. Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.

Specific activities will include:

  • Reviewing how microbiological quality may be impacted in steps throughout the manufacturing process
  • Identifying risk assessment tools, including the Failure Modes and Affects Analysis (FMEA) approach
  • Creating an example FMEA, incorporating process steps that may have microbial contamination risk
  • Using the FMEA approach to evaluate process and behavior

Who Should Attend

Individuals from the following areas will benefit from attending this course:

  • Manufacturing / Facility Management
  • Product Development
  • Project Management
  • QA/QC
  • Microbiology
  • Validation

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

  • Identify the aspects of pharmaceutical manufacturing which may affect microbiological quality
  • Develop an FMEA, quantifying risk for individual process steps
  • Quantitatively evaluate steps within a process
  • Develop ways to reduce or minimize activities that may increase microbial contamination risk



On or before September 3, 2018

After September 3, 2018


On or before September 3, 2018

After September 3, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 18, 2018, 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 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.

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:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852 USA


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Peter Noverini, MIcrobiologist

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 #382 | ACPE #0116-0000-17-042-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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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