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Practical Application of Quality Risk Assessment Tools - Option 1

May 21 - May 23, 2019
Bethesda, MD

  • Education
  • Western Hemisphere Events

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Overview

This training course will cover the 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.

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.

PREREQUISITES

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

  • 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 54 (TR 54), Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

Agenda

  • An agenda will be provided on the first day of the training course.

Trainers

Tiffany Baker
Tiffany Baker
Alnylam Pharmaceuticals
Scott Rudge
Scott 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

  • Accreditation

    Accreditation

    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 # / ACPE # / CEUs: 531 / 0116-0000-17-016-L04-P / 1.8
    Type of Activity: Application

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    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 (PDH) 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 PDH credits.

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Travel

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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 April 5, 2019
Member $2,429
Non-member $2,915
Gov't/Health Auth./Academic* $1,619



Regular Registration
Registration Type Price After April 5, 2019
Member $2,699
Non-member $3,239
Gov't/Health Auth./Academic* $1,619



* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Apr 20, 2019, no fee will be charged. After Apr 20, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Apr 20, 2019, a full refund will be given minus a $200 fee. After Apr 20, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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registration@pda.org

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