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

Nov 10 - Nov 12, 2020
Bethesda, MD

  • Education
  • The Americas

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

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Patrick Mains
Patrick Mains
Genentech
Scott R. Rudge
Scott R. Rudge
RMC Pharmaceutical Solutions Inc.

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

    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
    Manufacturing, Quality, Process Development, Quality Control

    Roles
    Supervisor, Specialist, Scientist, Manager, Analyst

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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 Washington/Bethesda area is serviced by the following airports: 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 do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

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.

Directions

Registration Fees

Early Registration
Registration Type Price By September 25, 2020
Member $2,429
Non-member $2,915
Gov't/Health Auth./Academic* $1,889





Regular Registration
Registration Type Price After September 25, 2020
Member $2,699
Non-member $3,239
Gov't/Health Auth./Academic* $1,889





* 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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Contact

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Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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