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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Quality Culture Transformation - Regulators Only

Apr 19 - Apr 20, 2018 |
Apr 20, 2018 |
| London, UK
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

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?

Learn to assess the quality culture maturity at your work site. This PDA course will provide you with the tools and knowledge to ensure that you collect verifiable data to create new processes that facilitate positive culture changes. Gain hands-on experience with assessment tools and collect feedback in the following categories: employee ownership, continuous improvement, technical excellence, leadership and commitment, and communication and collaboration. Come back to your organization with an assessment tool for determining the maturity level of your company’s quality culture and the ability to benchmark against PDA’s confidential database of other participants.

As ongoing support included with the training course, PDA will send an anonymous quality culture survey for all site staff to complete. PDA will collect and compile the results so that your site leadership will be able to gauge employees’ views of quality culture and have better understanding of where to take action, how to track progress, and which decisions to take to improve the site culture. You will also have access to PDA’s composite survey results so you know where you stand with your peers.

PDA Quality Culture Transformation Program

These are the resources included with your registration for the training course:

  1. COURSE: TWO seats in Hands-on active learning in a 2-day course on “Quality Culture Transformation”
  2. TOOL: Quantitative assessment of current quality culture at TWO manufacturing sites
  3. SURVEY: Blinded, direct employee feedback on aspects of your Quality Culture at TWO sites
  4. BENCHMARK: Compare your results against more than 40 sites from 24 companies in North America, Europe and Asia that have already completed their Quality Culture Assessments

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

Upon completion of this program, you will be able to:

  • Use the Quality Culture Maturity Assessment tool to collect data
  • Examine evidence to draw conclusions of culture level in a consistent manner
  • Use verifiable evidence of determine your company’s culture score
  • Engage site management and leadership in supporting the quality culture assessment
  • Engage site personnel to participate in the assessment and survey

Standard

Member and Nonmember

$4,999

Additional Options

Per Extra Attendee Enrolled
$4,000

Per Extra Site Participating
$1,500


PLEASE NOTE: If you are a regulator interested in participating, please contact us.

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 20, 2018, 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 info@pda.org 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:

London, UK

Contact

For more information, please contact:

David Talmage
Senior Director, Education
Tel: +1 (301) 656-5900 x137
Email: talmage@pda.org

Cylia Chen-Ooi, Sr. Manager, QA, Amgen, Inc.
Steven Mendivil, Sr. Advisor, International Quality External Affairs, Amgen, Inc.
Brianna Peterson, FDA Quality Expert, Boehringer Ingelheim Ellas
Continuing Education Credits are not offered for this program.
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