Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Quality Metrics and Quality Culture

Apr 06 - Apr 07, 2017 |
Apr 07, 2017 |
Anaheim Marriott | Anaheim, CA
  • Education
Add event to: ICal Outlook Google Calendar
Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

It has been a well-accepted practice of industry for decades that the business and the quality system must be managed using hard data. With the recent interest of FDA in quality metrics, our industry is recognizing that measuring process performance and subsequently taking action to improve the processes is the way to improve quality and significantly reduce costs at the same time. Evolving from the discussion of quality metrics the last few years has been the realization that culture has a bigger impact on performance than any set of metrics and that metrics will only produce their desired effect if the right culture is present.

The day on Quality Metrics will help the participants select the appropriate quality metrics, determine how best to collect the data and how to use the data to improve the quality system. The kinds of processes to be discussed include the production process; supporting processes such as change control, training and validation; supplier processes and materials management.

The day on Quality Culture will discuss the possible components of a quality culture, how to measure culture and how to change/improve the culture.

Who Should Attend

  • Senior management with the responsibility for the Quality System (QS) and its continuous improvement
  • Production management with the responsibility for the quality of core process and production
  • QA management with the responsibility to assist senior management in its responsibilities for the QS and for collecting, analyzing the quality metrics and presenting them in usable form

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

  • Identify what quality metrics or performance indicators your operation needs
  • Collect and analyze the appropriate quality metrics data in the most cost effective way and use the data to drive continuous improvement of the Quality System
  • Describe the desired culture for your company
  • Identify and prioritize cultural gaps, and develop a strategic plan for changing your company culture
  • Utilize tools for measuring the current culture and for progress in changing it



On or before February 20, 2017

After February 20, 2017


On or before February 20, 2017

After February 20, 2017

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 7, 2017, 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 or +1 (301) 656-5900.

Class Schedule

All lab 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.


This course will take place at:

Anaheim Marriott
700 West Convention Way
Anaheim, CA 92802
Phone: +1 (714) 622-3056


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

David Talmage, Director, Education, PDA

With over 15 years in the pharmaceutical, biopharmaceutical and consumer industries, David has expertise in the quality systems leading to extensive experience in all aspects of manufacturing, validation and inspection readiness, with a focus on process optimization and efficiency in resource utilization. His proficiencies include consent decree remediation efforts and management of quality systems, product tech transfer and rapid site growth training, pre-approval inspection readiness, commissioning and validation, and facility start-up.

David’s specializations include technical training and he currently serves as the Director of Education for the Parenteral Drug Association (PDA) where he is responsible for the development and delivery of PDA’s courses and the operation of the Training and Research Institute’s cleanroom and laboratories.

He has worked at Johnson & Johnson, MedImmune/AstraZeneca, Genzyme, Dendreon and Bayer HealthCare. David holds an MBA with a concentration on operations management and a BS in chemistry from Washington State University.

Continuing Education for Pharmacists

ACPEPDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #223 | ACPE #0116-0000-16-022-L04-P | 1.2 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.