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Parenteral Drug Association Connecting People, Science and Regulation ®

Quality Metrics and Quality Culture for Pharmaceutical Manufacturing - Australia

Sep 14 - Sep 15, 2017 |
Sep 15, 2017 |
Victoria University Convention Centre | Melbourne, Australia
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Participants will examine their quality management system, select the appropriate quality metrics that drive intended behaviors, and determine how best to collect and use the data to improve the quality system using the ICH Q10 guidance as framework for a practical and suitable methodology. Topics will also include how to conduct effective quality management reviews.

Participants will then compare and contrast application of quality metrics to drive and enhance the quality culture, including measuring their company’s current quality culture and formulating an action plan to transform the quality culture.

Who Should Attend

This course is for quality and manufacturing management responsible for the continuous improvement of the quality system (QS).

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

  • Identify appropriate quality metrics that drive intended behaviors and promote continuous improvement
  • Collect and analyze quality metrics data to communicate quality culture and drive actions and decisions to improve the quality system
  • Describe the desired quality culture for your company
  • Utilize tools to measure the current quality culture
  • Develop an action plan for transforming your company’s quality culture

Standard

Member

On or Before July 31, 2017
$1,050 AUS ($788 USD)

After July 31, 2017
$1,200 AUS ($900 USD)

Nonmember

On or Before July 31, 2017
$1,450 AUS ($1,088 USD)

After July 31, 2017
$1,600 AUS ($1,200 USD)

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 15, 2017, you will receive a full refund less a $200 USD 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.

General Course Information

Please arrive at the 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 between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

Location

Victoria University Convention Centre
Level 12, 300 Flinders Street
Melbourne, Vic, 3000

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
PDA USA
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

David Spaulding
Partner/Training Manager
SeerPharma Pty Ltd
Australia
Tel: +61 3 9897 1990
Email: david.spaulding@seerpharma.com.au

David B. Talmage, Senior 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.

This course does not provide Continuing Education Units (CEUs) for pharmacists.

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