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Parenteral Drug Association Connecting People, Science and Regulation ®

Quality Risk Management Facilitator Training - New Course

Jun 12 - Jun 14, 2018 |
Jun 14, 2018 |
| Bethesda, MD
  • Education
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Duration:  3 days
Time: 8:30 a.m. - 4:00 p.m.

Since ICH Q9 was first introduced, the industry has been working toward effective implementation and execution of Quality Risk Management. On the road to compliance, one of the barriers in the effective execution of risk management has been the lack of personnel to confidently lead and facilitate complex risk activities. Strong facilitator skills are instrumental when guiding teams through risk management activities. Organizations can thrive when their risk program is effectively, consistently and pragmatically practiced through the use of risk facilitators.

Risk Facilitators have the unique role of engaging multiple disciplines in the risk management process and with this role comes the opportunity to explore the vulnerabilities of an organization (i.e., the risky business). This course will guide individuals in navigating the risk management process as a Risk Facilitator. The attendees will gain perspective on the Risk Facilitator role, identify the key elements of developing and communicating a risk plan, and work with real-life case studies to demonstrate their ability to successfully lead a risk activity, overcome perception, improve personal insights and develop the ability to control biases and other obstacles along the way.

Prerequisites

IMPORTANT NOTE: Participants enrolling in this course must have completed two PDA courses:

  • Foundations of Quality Risk Management scheduled on December 11, 2017 at the PDA Training and Research Institute in Bethesda, Maryland.
  • Practical Application of Quality Risk Assessment Tools scheduled on December 12-14, 2017 at the PDA Training and Research Institute in Bethesda, Maryland.

If you are interested in registering for this course but have not completed the two courses as prerequisites above, you will be required to submit your CV and participate in a phone interview to demonstrate your competency in risk management principles and formal risk management tools (i.e., PHA, FMEA, HACCP). Please contact Stephanie Ko at ko@pda.org for more details.

Who Should Attend

Individuals who will benefit from this course have the task to facilitate or help teams through risk management activities, making sure that that the right tools are chosen and that the tools are used as intended to meet the desired outcome in an effective way.

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

  • Identify characteristics of a strong risk facilitator, ensuring that objectives are met effectively, consistently and pragmatically
  • Define the purpose of a risk facilitator
  • Recognize and overcome bias and heuristics (including the personal preferences and bias in the facilitator)
  • Define the objectives of a given risk management process and develop a risk management plan
  • Communicate the risk plan and the outcome of the risk management process to relevant stakeholders
  • Outline potential pitfalls and how to overcome them

Standard

Member

On or before April 30, 2018
$2,294

After April 30, 2018
2,549

Nonmember

On or before April 30, 2018
$2,753

After April 30, 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 May 14, 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 #532 | ACPE #0116-0000-18-006-L04-P | 1.8 CEUs
Type of Activity: Application

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 (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 18 PDHs.

Cancelled

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