Quality Culture and Investigations: Best Practices
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Individual Registration
Group Registration
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.
Duration: 2 Days
Agenda
Discover What's Happening Each Day
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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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 NWWashington, 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
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.
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