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QRM Decision Maker

Dec 11 - Dec 13, 2017
Bethesda, MD

The track addresses a decision-maker’s role in the QRM process and will strengthen learners’ competencies to enable robust risk-based decisions and success of QRM activities.

  • Education
Required courses:  2 courses
Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

Course 1 Title: Foundations of Quality Risk Management

This course will provide an overview of the Quality Risk Management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle. The course will further build on the conceptual lessons, by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

Important Note

This course is an updated version of a prior PDA course, “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation.” Please note that the content of both courses is similar. If you have already taken “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation,” we recommend that you consider taking “Foundations of Quality Risk Management” only as a refresher.


Course 2 Title: Quality Risk Management: Risk Control and Risk-Based Decision-Making

To control risk, decisions must be made as part of the quality risk management (QRM) process. Risk-based decision-making tends to be more dynamic and less structured than the other steps of the QRM process. A decision-maker’s role in the QRM process is critical for timely, effective and ongoing management of risks. The course will provide participants with the ability to interpret the appropriateness and adequacy of risk control mechanisms. Attendees will also explore the overall concepts of risk-based decision-making including risk tolerance, its impact on the success of risk management, and how to manage diversity in risk tolerance across your organization. The course will strengthen learners’ competencies to identify and assess the results of a QRM exercise in order to enable robust risk-based decisions and enable success of QRM activities.

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

  • Foundations of Quality Risk Management” taking place Monday, December 11, 2017 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 Decision Maker track includes two courses: “Foundations of Quality Risk Management” and “Quality Risk Management: Risk Control and Risk-Based Decision-Making.” This training module is applicable to supervisors, managers and directors from disciplines such as quality assurance, quality control, engineering, validation, production and technical services, who often make decisions based on the outcomes of risk assessments for their areas of responsibility.

Agenda

  • Course 1 Title: Foundations of Quality Risk Management

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

    • Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
    • Describe when, where and how to apply risk management throughout the product lifecycle
    • Plan and prepare for quality risk management activities
    • Describe the formality associated with QRM tools
    • Describe the purpose of a risk register
    • Build a QRM program at your company

    Course 2 Title: Quality Risk Management: Risk Control and Risk-Based Decision-Making

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

    • Explain the roles and responsibilities of decision makers in the QRM process
    • Assess the elements of risk-based decision making
    • Apply risk-based decision principles as part of QRM activities
    • Use risk assessment outcomes and risk register to define the most appropriate risk mitigation strategy
    • Differentiate between the types of risk control mechanisms and how to apply them
    • Examine how level of risk tolerance in an organization can impact risk control priorities and ultimately the effectiveness of QRM

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 150
Bethesda, MD

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Registration Fees

Regular Price

Standard

Member

On or before October 27, 2017
$2,249

After October 27, 2017
$2,499

Nonmember

On or before October 27, 2017
$2,699

After October 27, 2017
$2,999


Government/Health Authority/Academic

Member

$1,499

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by November 10, 2017, 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 [email protected] or +1 (301) 656-5900.

Class Schedule

All courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your 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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

This course will take place at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* 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 [email protected] 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 [email protected]. Phone messages are not accepted.

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

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