Quality Culture and Investigations: Best Practices

14 Sep - 15 Sep 2017
Washington, DC

Become a Sponsor and/or Exhibitor

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.

Time: 8:30 a.m. – 4:00 p.m.
Duration: 2 Days

Agenda

Discover What's Happening Each Day
Day 1 14 Sep
Thursday, 14 September

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

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Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC United States

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

Registration

Pricing Options

More information coming soon.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

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.

Become a Sponsor and/or Exhibitor

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Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the Quality Culture and Investigations: Best Practices! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

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Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the Quality Culture and Investigations: Best Practices! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

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