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Parenteral Drug Association Connecting People, Science and Regulation ®

Quality Culture and Investigations: Best Practices

Sep 14 - Sep 15, 2017 |
Sep 15, 2017 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Education
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Time: 8:30 a.m. – 4:00 p.m.
Duration: 2 Days

Comprehensive investigations serve a number of purposes other than being in compliance with regulatory requirements, including decreasing the cost of quality, improving efficiency and reducing repeat events. This course is designed to present the critical support elements of investigations, including quality culture, integration of quality risk management and continuous improvement. Topics will also include understanding how effective investigations and well-written reports yield business improvement opportunities. Participants will learn the necessary components in designing an investigation and conducting a root cause analysis which will determine the true root causes and yield the most effective CAPAs.

Who Should Attend

This course is for upper level management, operational supervisors and professionals in quality assurance/quality control, risk management, regulatory affairs, manufacturing, product development, CAPA, supply chain and purchasing, production, engineering, project management, and R&D.

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

  • Examine key cultural aspects affecting investigations, assess how they impact investigations and develop a strategy for dealing with them
  • Conduct a review/assessment of your company culture and provide ways to help senior management to understand the value of well-done investigations
  • List appropriate skill sets and functions necessary to participate on the investigation team
  • Conduct effective investigations which determine true root cause and cost effective CAPAs
  • Define after-action reviews to determine effectiveness and lessons learned
  • Recognize quality risk management principles to evaluate/prioritize deviations to determine the extent and depth of investigations
  • Identify the components of investigation reports which accurately summarize investigation findings and lead to clear conclusions and follow up
  • Explain the business value and impact of well-done investigations and how they can reduce repetitive investigations and lower business costs



On or before July 31, 2017

After July 31, 2017


On or before July 31, 2017

After July 31, 2017

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 15, 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 or +1 (301) 656-5900.

Class Schedule

All lecture 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.


The course will be held at:

Renaissance Washington D.C. Hotel
999 9th St NW
Washington, D.C. 20001 USA
Phone: +1 (202) 898-9000


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Chuck Bornhoeft, Associate Director – Integrated Quality Management, Upsher-Smith Laboratories, LLC

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 #524 | ACPE #0116-0000-17-001-L04-P | 1.2 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 12 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 12 PDHs.