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PDA 531 Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

Aug 01 - Aug 03, 2023
Bethesda, MD

  • Education
  • The Americas
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Overview

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

Attendees will also get hands-on practice with the more detailed and structured risk assessment tools - PHA, FMEA and FTA. 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.

Participants will also receive a free copy of:

  • PDA Technical Report No. 54-2: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling
  • PDA Technical Report No. 54-4: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances

PREREQUISITES

This training course is part of PDA's QRM Application Track. Participants enrolling in this training course must have completed one of the following PDA training courses:

  • PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management
  • Any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

Additionally, participants should have read PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Risk Management Training Courses

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Bryan Abney
Bryan Abney
Syner-G Biopharma Group
Bio
Bryan Abney
Syner-G Biopharma Group

Mr. Abney has been in the pharmaceutical industry since 1993 working for a variety of companies from small start-ups to large industry giants. Most recently, he is the head of quality at Syner-G Biopharma Group, a consulting firm specializing technical, regulatory, and quality aspects of pharmaceutical development and submission. Today, Mr. Abney leads a team assisting companies with building quality systems, creating strong quality cultures and strategies, and day-to-day QA support. He holds a M.S. Degree from the University of Missouri, St. Louis in Organic Chemistry.
Patrick Mains
Patrick Mains
ValSource Inc.
Bio
Patrick Mains
ValSource Inc.

Patrick Mains is currently a Senior Consultant at ValSource. He supports organizations in the pharmaceutical industry using his expertise in Quality Risk Management. He holds a Bachelor’s Degree in Biochemistry and Cell Biology and a certificate in Project Management from the University of California, San Diego Extension. Patrick is a Project Management Institute (PMI) certified Project Management Professional (PMP). With over 29 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 Roche/Genentech.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply the formality spectrum concept for risk assessment tools
    2. Explain why and how tool selection is important in ensuring the right outcomes and decisions from a QRM application
    3. Examine considerations when selecting the appropriate risk assessment tool
    4. 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
    5. Use structured risk assessment tools such as PHA, FMEA and FTA
  • Who Should Attend

    This training course is intended for professionals who apply quality risk management tools related to chemistry, manufacturing and controls, process development and process engineering and management.

    Departments
    Quality Control, Manufacturing, Quality Assurance Operations

    Roles
    Analyst, Specialist, Supervisor, Manager, Scientist

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By June 17, 2023
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749

Regular Registration
Registration Type Price After June 17, 2023
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic* $1,749

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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