Skip To The Main Content

Quality Culture Assessment Tool and Training

Dec 08 - Dec 09, 2020
Carlsbad, CA

  • Education
  • The Americas
Cancelled
 

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

Ask a Question

Agenda

Download full 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
Rion
Bio
Chuck Bornhoeft
Rion

Chuck Bornhoeft brings over 20 years of biotech and pharma experience to Rion as Vice President of Quality Operations. Mr. Bornhoeft is a proven quality leader with a passion for building and maintaining a strong quality culture. Prior to joining Rion in July 2021, he has supported biologics, small molecule NDA and ANDA products, dietary supplements, and cosmetic products throughout his career at Upsher-Smith Laboratories and Johnson and Johnson. He has extensive experience with internal and external manufacturing and packaging production, quality systems, product development, process improvement, laboratory oversight, and on-market product support. In addition to his work experience, Mr. Bornhoeft is a current Regulatory and Quality Advisory Board member with the Parenteral Drug Association. He holds a MS and BS in chemistry from Villanova University and the University of Wisconsin-Madison.
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. 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

    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

Contact Us

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 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].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

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

PDA Members Save Substantially