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PDA Quality Risk Management Certificate Program

Dec 11 - Dec 14, 2017
Bethesda, MD

Receive training on industry leading topics by experts in the Quality Risk Management (QRM) field. Select the track that best suits your needs to gain knowledge and proficiency in fulfilling your unique role at your company.

  • Education

PDA is launching its new Quality Risk Management Certificate Program.

This first-of-its-kind Program in the industry delivers role-based training to help your company improve its quality risk management (QRM) process to ultimately ensure the delivery of higher-quality, safe medications to patients.

Nowhere else can you receive training on the critical aspects of the QRM process from noted industry experts intimately involved in the development and implementation of the ICH Q9 guidance and with years of experience in training and practical application of QRM principles

To maximize the benefit of this unique training opportunity, select the track that best suits your needs to gain knowledge and proficiency in fulfilling your unique role at your company:

  • QRM Foundations Track: The course, “Foundations of Quality Risk Management,” is designed for all personnel involved in quality risk management activities, as a participant in risk assessments, QRM facilitator or decision maker. This includes personnel from disciplines like quality assurance, quality control, engineering, validation, production and technical services who are involved in QRM activities. This course is a prerequisite for all tracks listed below.
  • QRM Application Track: This track 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.
  • QRM Decision Maker Track: This track 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. How well decision makers understand and execute their roles in the QRM process has a direct impact on the effectiveness of risk mitigation and product quality. Misinformed decisions can result in inadequate mitigation of product quality risks and ultimately lead to product defects and product recalls; find out how to protect against such outcomes by enabling robust risk-based decisions.
  • QRM Facilitator Track: Coming in 2018, this track will be the most comprehensive of the four tracks and is applicable to individuals who are expected to be highly skilled and proficient in the entire QRM process and its application, including the use of the various QRM tools. QRM facilitators can reside in various functions across an organization including project management, operational excellence and technical functions.

Required Courses

Foundations of Quality Risk Management
December 11, 2017

Foundations of Quality Risk Management
December 11, 2017

Quality Risk Management: Risk Control and Risk-Based Decision-Making
December 12-13, 2017

Foundations of Quality Risk Management
December 11, 2017

Practical Application of Quality Risk Assessment Tools
December 12-14, 2017

Overview

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Agenda Coming Soon

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Additional Information

  • Learning Objectives

    Learning Objectives

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  • Who Should Attend

    Who Should Attend

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Travel

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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

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* 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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Contact

Program Inquiries
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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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Tel: +1 (301) 656-5900 ext. 115
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