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Quality Culture Transformation Resources

Apr 17 - Apr 18, 2018
Mainz, Germany

Take the first step on a journey to transform your Quality Culture with resources developed by PDA volunteers specifically for pharmaceutical manufacturing sites.

  • Education
  • Europe

Overview

What are most important positive quality culture behaviors that impact product quality?

Can you identify which mature quality attributes have the biggest impact on quality culture behavior?

Would you like to quantify the strengths and weaknesses of quality culture maturity at your plant site?

Take the first step on a journey to transform your Quality Culture with resources developed by PDA volunteers specifically for pharmaceutical manufacturing sites.

Following a successful pilot conducted over the last 18 months, PDA is pleased to launch the Quality Culture Transformation Resources to the industry.

When you enroll in this new program, PDA will train your assessors, teach you how to use the Maturity Model, offer an anonymous survey to your site staff and give you access to PDA’s composite benchmarking results so you know where you stand with your peers.

Your site leadership will be able to gauge employees’ views of quality culture and have a better understanding of where to take action, how to track progress, and which decisions to take to improve the site culture.

Who Should Attend

This program will benefit pharmaceutical and biopharmaceutical manufacturing leaders who want to measure quality culture maturity at their plant sites and identify areas for improvement.

It will also prepare your assessors to conduct site evaluations in a consistent and verifiable manner using the PDA Model and Tools.

Faculty

Denyse Baker, PDA Director of Science and Regulatory Affairs
Denyse Baker is the Director of Scientific and Regulatory Affairs at PDA. She has 30 years of pharmaceutical industry and regulatory authority experience. Denyse holds the RAC designation in both US and European regulatory affairs and is a registered professional engineer. She is a leader in PDA’s pharmaceutical quality and culture metrics programs, contributor to the PDA Letter and PDA Journal, as well as the coordinator for PDA regulatory commenting globally and PDA taskforces working on data integrity and post approval change concerns within the pharmaceutical industry.
Email


Cylia Chen-Ooi, Senior Manager Amgen Operations Intelligence Program, Amgen
Cylia leads the Amgen Operations Intelligence Program which keep abreast with worldwide GMP/GDP regulatory requirements, inspectional and industry trends. In her current role, she also develops the external engagement strategy for Amgen and is actively engaged with several industry associations. She is currently the leader of PDA Quality Culture Task Force Team and have led a panel of experts from industry and regulators to develop tools to help industry advance understanding and maturity of quality culture at their companies. Prior to her current role, she led several initiatives for Amgen’s international expansion plan and she has extensive experience in fill finish process development. She holds a Master’s degree in Regulatory Science and B.S. degree in Biomedical Engineering from University of Southern California.


Steven Mendivil, Senior Advisor, Amgen
Steven Mendivil is currently a Senior Advisor to Amgen Quality leadership. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He managed a group responsible for identifying and reviewing new or revised GMP & GDP documents for impact as well as managing Amgen external activities related to GMP & GDPs. Previously, Steve held positions as the Head of Corporate Quality GMP & EHS Compliance and Amgen Global Operation Leader managing various biotech products from preclinical through commercial development. Steve is currently PDA’s Quality Metric Task Force leader. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex and Syva in Regulatory Affairs, Quality and Manufacturing encompassing both the pharmaceutical and medical device industries. Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.


Brianna Peterson, Compliance Expert, Boehringer Ingelheim
Brianna Peterson is an experienced quality professional, serving within the pharmaceutical industry for 15 years. She is currently serving as a compliance expert in Athens, Greece for Boehringer Ingelheim. Recently, with a global role, Brianna partnered with sites within Asia, Europe, and the Americas to strengthen their Quality Culture. Previously, Brianna worked within US pharma for 10 years within Quality Assurance/Systems, Quality Control, and Development functions. Brianna has been an active member of the PDA Quality Culture team since 2015.

Agenda

  • Tuesday, 17 April 2018

    9:00
    Welcome and Introduction (Breakfast)


    9:30
    Vision & Background


    10:00
    Coffee Break

    10:30
    Behaviors vs. Attributes


    11:30
    Audit Logistics & Tools


    12:00
    Lunch Break

    13:00
    Intro to the Case Study & Exercise


    13:30
    MOCK ASSESSMENT
    Employee Empowerment

    • Understanding quality goals
    • Safety culture

    15:00
    Coffee Break

    15:30
    Continuous Improvement

    • CAPA robustness
    • Management review and metrics
    • Clear quality objectives
    • Internal stakeholder feedback

    17:00

    End of Day 1

    Wednesday, 18 April 2018

    8:30
    MOCK ASSESSMENT CONTINUES
    Technical Excellence

    • Utilization of new technologies
    • Maturity of systems (QMS, QRM, DI)

    10:00
    Coffee Break

    10:30
    Leadership Commitment to Quality

    • Accountability and quality planning
    • Enabling capable resources

    Quality Communication and Collaboration
    • Quality communications
    • Communication and collaboration

    12:00
    Lunch Break

    13:00
    Characteristics of a Successful Assessor


    13:30
    Learning from Previous Site Participants – Understanding Scores


    14:30
    Getting Site Management Involved and Setting Expectations


    15:00
    Wrap Up, Feedback


    15:30
    End of Program

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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.

FAVORITE Parkhotel Mainz

Karl-Weiser Str. 1
Mainz, Germany

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Directions

Registration Fees

Regular Price

Ways to register

  • PLEASE NOTE: Online registration is not available. Please complete the registration form to register.
  • FAX: +49 30 436 55 08 66
  • [email protected]

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?

PLEASE NOTE:The registration fees include TWO course seats and quantitative assessment at TWO manufacturing sites.

Member and Nonmember

By 16 February 2018
6.800 Euro

After 16 February 2018
8.100 Euro

Additional Options

Per Extra Attendee Enrolled
3.400 Euro

Per Extra Site Participating
1.300 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

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

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Tel: +1 (301) 656-5900
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