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Quality Culture and Investigations: Best Practices

Sep 14 - Sep 15, 2017
Washington, DC

This course is designed to present the critical support elements of investigations, including quality culture, integration of quality risk management and continuous improvement.

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

Overview

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

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

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or before July 31, 2017
$1,709

After July 31, 2017
$1,899

Nonmember

On or before July 31, 2017
$2,051

After July 31, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

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 [email protected] 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.

Location

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

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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