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Parenteral Drug Association Connecting People, Science and Regulation ®

Foundations of Quality Risk Management - November

Nov 05 - Nov 05, 2018 |
Nov 05, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:30 p.m.

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.

Who Should Attend

This course is designed for risk assessment participants, QRM facilitators or decision makers who are new to QRM or need to refresh their knowledge in QRM basics. This includes personnel from disciplines like quality assurance, quality control, engineering, validation, production and technical services who are involved in QRM activities.

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
  • Building a QRM program at your company

Standard

Member

On or before September 21, 2018
$1,192

After September 21, 2018
$1,325

Nonmember

On or before September 21, 2018
$1,431

After September 21, 2018
$1,590


Government/Health Authority/Academic

Member

$795

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

Lori Richter, Senior Consultant, Valsource, LLC

Lori Richter is a Senior Consultant at ValSource. She holds a Microbiology degree and over 18 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Her most recent role included developing an Integrated Risk Management program focused on strategic risk and business continuity management. Prior to that she held a global team role, developing and deploying a Quality Risk Management (QRM) program across the Roche Pharmaceutical Division, including developing tools, templates, and training materials, and integrating QRM into Quality Systems. She is currently a team member of the Parenteral Drug Association (PDA) Task Force, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”, authoring TR 54-5.

Amanda B. McFarland, Senior Consultant, Valsource, LLC

Amanda Bishop McFarland, M.S. is a Quality Risk Management and Microbiology Consultant with Valsource, LLC with over 15 years industry experience. She specializes in the creation and implementation of Risk Management programs and in developing risk-based strategies for use in Microbiology. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology both from the University of Florida. Amanda is an active member of the Parenteral Drug Association (PDA); a faculty member of the PDA’s Quality Risk Management training series and the Quality Risk Management Interest Group co-lead.

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 #529 | ACPE #0116-0000-17-014-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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 6 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 (PDHs) 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 6 PDHs.

Register Now
https://www.pda.org/docs/default-source/website-document-library/training-courses/2018/qrm-certificate-program-november/registration-form

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