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Quality Culture Assessment Tool and Training

Dec 08 - Dec 09, 2020
Carlsbad, CA

  • Education
  • The Americas
 

Overview

The FDA continues to focus on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. In 2018, the FDA released a published document, in which they have called for routine assessment and management oversight of quality culture.

Make sure your company stays ahead of the curve and prepare for this reporting on quality culture with this comprehensive training course, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

During this training course, you will learn how to use PDA's quality culture assessment tool to effectively collect verifiable data and feedback in the following areas:

  • Employee Ownership and Engagement
  • Continuous Improvement
  • Technical Excellence
  • Leadership Commitment
  • Communication and Collaboration

As a result, the tool will allow you facilitate positive culture changes and continuous improvement within your organization.

PDA will also provide you with two complimentary resources to further enhance the value of your results:

  • Quality Culture Survey | PDA will send an anonymous quality culture survey for all staff at your site to complete, after which PDA will collect and compile the results enabling leadership to gauge employee views on quality culture and identify areas for improvement.
  • Benchmarking Data | Your site will be provided with exclusive access to the consolidated, blinded results from more than 50 sites from 30+ companies in North America, Europe, and Asia that have already completed the quality culture assessment.

Take the first steps toward evaluating the quality culture at your site and identifying opportunities for improvement by enrolling in this training course. The quality of your product and the safety of patients depends on it!

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Assurance Training Courses

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

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

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Use the Quality Culture Assessment Tool to identify strengths and opportunities for improvements across five key dimensions of quality culture
    2. Examine evidence to consistently assess culture metrics in a wide variety of manufacturing settings
    3. Use verifiable evidence to determine your company’s culture score
    4. Explain the importance of strong quality culture in a manufacturing operation
    5. Support leadership to engage site personnel in improving quality culture
  • Who Should Attend

    Who Should Attend

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

    Departments
    Quality Assurance, Manufacturing, Quality Control, Packaging, Regulatory Affairs

    Roles
    Supervisor, Manager, Director

Got a Question? We have answers

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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.

Open Biopharma Research and Training Institute

1958 Kellogg Avenue
Carlsbad, CA

How to Get Here

By Air

The nearest airport to the training course location is the San Diego International Airport (SAN).

By Car

There is a parking lot available at the training course location.

Other Options

N/A

Directions

Registration Fees

Early Registration
Registration Type Price By October 24, 2020
Member $2,429
Non-member $2,915
Gov't/Health Auth./Academic* $1,889


Regular Registration
Registration Type Price After October 24, 2020
Member $2,699
Non-member $3,239
Gov't/Health Auth./Academic* $1,889



* 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 by Nov 24, 2020, no fee will be charged. After Nov 24, 2020, 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 by Nov 24, 2020, a full refund will be given minus a $200 fee. After Nov 24, 2020, 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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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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