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Practical Application of Quality Risk Assessment Tools - July

Jul 10 - Jul 12, 2018 |
Jul 12, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  3 days
Time: 8:30 a.m. - 4:00 p.m.

This course will cover application of various quality risk assessment tools and considerations for tool selection. Different case studies from drug substance manufacturing and packaging and labeling will be used to demonstrate application of the various tools.

Learners will understand how to apply the formality spectrum for tool selection and learn where simpler risk assessment tools can be more useful instead of detailed tools. They will also learn how different tools can be applied in combination to address a risk question.

Additionally attendees will get hands-on practice with the more detailed and structured risk assessment tools - PHA, FMEA and FTA as follows. In each of the application case studies all stages of the QRM process will be covered including identification of risks, risk controls, estimating residual risks, practicing documentation and communication of outcome to management, and obtaining approval from decision makers.

  • First, learners will practice performing a preliminary hazard analysis (PHA) to identify hazards, harms, and hazardous situations associated with a proposed protein drug substance packaging suite, and a bottling and packaging operation of oral non-sterile liquid product.
  • Second, learners will perform a failure mode and effect analysis (FMEA) to assess the potential product quality risks associated with a protein A chromatography process, and a secondary packaging components production process. Application of FMEA will include identifying specific failure modes, failure effects, and cause of the failures associated with potential risks during manufacturing and packaging.
  • The third case study involves use of the fault tree analysis (FTA) to identify and assess potential product quality risks, specifically with a virus contamination event in cell culture, and packaging, handling and transport of liquid filled glass syringe.


IMPORTANT NOTE: Participants enrolling in this course must have completed one of the following PDA courses:

  • Foundations of Quality Risk Management scheduled on December 11, 2017 or July 9, 2018 at the PDA Training and Research Institute in Bethesda, Maryland.
  • Any offerings of the prior PDA course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

Additionally, participants should have read PDA Technical Report 54 (TR 54), Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

Who Should Attend

The QRM Application track includes two courses: “Foundations of Quality Risk Management” and “Practical Application of Quality Risk Assessment Tools.” This training module is applicable to pharmaceutical professionals engaged in QRM application activities related to chemistry, manufacturing and controls for pharmaceutical and biotechnology processes. This includes: manufacturing supervisors/managers/directors, process development biochemists, microbiologists, cell biologists and molecular biologists, process engineers, quality assurance professionals, regulatory CMC supervisors/managers/directors, quality control and analytical development professionals.

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

  • Apply the formality spectrum concept for risk assessment tools
  • Explain why and how tool selection is important in ensuring the right outcomes and decisions from a QRM application.
  • Examine considerations when selecting the appropriate risk assessment tool
  • Demonstrate where and how application of simple risk assessment tools such as checklists, simple decision trees, technical assessments etc. can be used as alternatives to more detailed risk assessment tools such as PHA, FMEA, FTA
  • Use structured risk assessment tools such as PHA, FMEA and FTA



On or before May 25, 2018

After May 25, 2018


On or before May 25, 2018

After May 25, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by June 11, 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:

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:

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

Scott Rudge, COO and Chairman, RMC Pharmaceutical Solutions, Inc

Since co-founding RMC Pharmaceutical Solutions in May 2004, Scott has been involved in a wide variety of projects for small and large biotech/pharmaceutical companies. He has overseen and/or performed assay, equipment, sterilization, cleaning and process validation, formulation development, due diligence for a multimillion dollar investment, construction of a new GMP facility for tissue processing, and tech transfer for a major late stage biotechnology product. In his last position, Scott served as the Vice President of Operations at FeRx Incorporated, overseeing manufacturing, process and product development, analytical development, formulation, facility design, construction and operation, and intellectual property.

Patrick Mains, Principal Quality Engineer, Project and Risk Management, Global Quality Services, Genentech

Patrick Mains is currently a Principal Quality Engineer at Genentech, supporting the design, deployment, realization and governance of a harmonized GMP compliant Quality Risk Management Program for the Roche Pharma network. He holds a Bachelor’s Degree in Biochemistry and Cell Biology and a certificate in Project Management from the University of California, San Diego. Patrick is a Project Management Institute (PMI) certified Project Management Professional (PMP). With over 24 years of experience in the biopharma industry, Patrick has had various roles in Quality Control, Project Management, Site Compliance/Inspection Management, Quality Systems, and Global Quality at IDEC Pharmaceuticals, Biogen Idec, and most recently Roche/Genentech.

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 #531 | ACPE #0116-0000-17-016-L04-P | 1.8 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 18 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 18 PDHs.