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Practical Application of Quality Risk Assessment Tools - November

Nov 06 - Nov 08, 2018
Bethesda, MD

This track will cover application of various quality risk assessment tools and considerations for tool selection. 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.

  • Education

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Duration:  3 days
Time: 8:30 a.m. - 4:00 p.m

Overview

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.

Prerequisites

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, July 9, 2018, or November 5, 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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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:
    Type of Activity: Not Applicable

    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 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 PDH credits.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

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Registration Fees

Regular Price

Standard

Member

On or before September 21, 2018
$2,294

After September 21, 2018
2,549

Nonmember

On or before September 21, 2018
$2,753

After September 21, 2018
$3,059


Government/Health Authority/Academic

Member

$1,529

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 8, 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 info@pda.org 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.

Location

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

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

* 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 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, 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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Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

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

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Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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