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PDA 538.2 Quality Culture Assessment

Apr 06, 2023
New Orleans, LA

  • Education
  • The Americas
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Overview

Make sure your company stays ahead of the curve! Prepare for this reporting on quality culture with PDA’s comprehensive Quality Culture Assessment Tool, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

In this training course, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you to facilitate positive culture changes and continuous improvement within your organization.

The goal is to ensure that a quality mindset and behaviors are embedded into the daily work of the individuals involved in all functions to ultimately ensure the delivery of high-quality products to patients.

At the end of this training, you will be provided with the following tools to begin assessing your company’s quality culture:

  • PDA Quality Culture Assessment Tool
  • Matrix and Example Interview Questions
  • Site Kick Off/Leadership Presentation
  • Pre-Audit Questionnaire
  • Quality Culture Survey
For more options and/or related training courses, please visit the page(s) below.

PDA Quality and Compliance Training Courses

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.

Trainers

Chuck Bornhoeft
Chuck Bornhoeft
Upsher-Smith Laboratories, LLC
Bio
Chuck Bornhoeft
Upsher-Smith Laboratories, LLC
Steven R. Mendivil
Steven R. Mendivil
Amgen Inc.
Bio
Steven R. Mendivil
Amgen Inc.

Steven Mendivil is currently a part time contractor and Senior Advisor for Amgen in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex in Regulatory Affairs, Quality and Manufacturing. Steve also consults for a number of companies.

He was on the PDA Board of Directors as an Executive Officer and has led various external committees on GMP related topics. Steve is currently PDA’s Quality Metric /Culture Task Force leader.

He has also taught at UC Berkley extension course on Biotechnology and at USC graduate school for Regulatory Affairs.

Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Have an aligned understanding of the Quality Culture Assessment Program
    2. Perform their role as an assessor to properly conduct the assessment process
    3. Score and report assessment results
    4. Prepare for a successful site assessment
  • Who Should Attend

    This training course is intended for professionals who want to measure and assess their company’s quality culture.

    Departments
    Quality Systems, Quality Compliance, Manufacturing, Quality Assurance Operations

    Roles
    Supervisor, Manager, Director

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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.

Hyatt Regency New Orleans

601 Loyola Avenue
New Orleans, LA

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  • Accommodations

    Rate: $255 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 03 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations

    Online: Click on the reservation link above
    Phone: +1 (504) 561-1234, make sure to give the PDA Group Code, G-PDAA, to receive the discounted conference rate

    Individual Cancellation

    72 hours prior to 23:59 local time of the day of arrival to check-in to avoid one night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Discover the culture of the Crescent City at Hyatt Regency New Orleans. Centered downtown near Champions Square, Smoothie King Center, and minutes from the historic Mississippi Riverfront. There's no better place from which to explore the eclectic vibrancy of New Orleans.

    Hyatt Regency New Orleans is conveniently located near many popular attractions. They’re only a few minutes walk from the French Quarter and the Arts District. Or hop on the city’s famous streetcars — the Loyola line stops directly outside the hotel.

How to Get Here

By Air

Louis Armstrong New Orleans International Airport (MSY) is approximately 15 miles (24km) from the hotel and all major carriers service this airport. Taxi fares from MSY are approximately $36 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency New Orleans is located at 601 Loyola Avenue, New Orleans, LA 70113. Valet parking is offered at the hotel and there are several nearby parking lots, including the 1301 Girod Parking Garage that connects directly to the hotel. Contact Merit Parking to confirm pricing: +1 (504) 561-0575.

Other Options

Hyatt Regency New Orleans is happy to partner with a local shuttle service to make your trip to and from the Louis Armstrong New Orleans International Airport easy. To learn more and to reserve your spot at least 24 hours prior to your flight arrival time, visit airportshuttleneworleans.com/portals/hyatt-regency-new-orleans.

Directions

Registration Fees

Early Registration
Registration Type Price By February 20, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699

Regular Registration
Registration Type Price After February 20, 2023
Member $999
Non-member $1,199
Gov't/Health Auth./Academic $699

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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