FDAnews Announces Designing and Sustaining Drug Stability Testing Programs: How to Extend Product Shelf Life Virtual Conference, Sept. 30

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The pressure to develop compliant and cost-effective drug stability testing programs is enormous. In this 6-hour virtual conference expert Charity Ogunsanya of Pharmabiodevice Consulting will provide in-depth training on protocol design, testing, storage, data management, trending and expiration dating extrapolations for approved products or new or existing products in the IND or NDA stage.

Designing and Sustaining Drug Stability Testing Programs:
How to Extend Product Shelf Life
**FDAnews Virtual Conference**
Sept. 30, 2014 — 10:00 a.m. – 4:00 p.m. EDT
http://www.fdanews.com/StabilityStudiesVC

The pressure to develop compliant and cost-effective drug stability testing programs is enormous.

In today’s hyper-competitive market, management wants products approved and on the market faster than ever. And they want them to stay on shelves longer.

So the cost of getting any part of a stability testing program wrong can result in significant wasted resources, delayed approvals and lost revenue.

For example, by miscalculating an expiration date the product could be removed too early and reduce potential revenue or leave product on the shelf too long and impact patient health.

FDAnews and noted stability expert Charity Ogunsanya of Pharmabiodevice Consulting, have manufacturers covered.

In this 6-hour virtual conference Ms. Ogunsanya will provide in-depth training on protocol design, testing, storage, data management, trending and expiration dating extrapolations for approved products or new or existing products in the IND or NDA stage.

Attendees will learn:

  •     The latest regulatory guidance on the requirements of a product’s stability testing program.
  •     Defining the program requirement specific to the type of product — it’s more confusing that manufacturers might think.
  •     Understanding the universe of new product stability indicator tests, and the rationale for choosing the right test and its impact on a product’s shelf life.
  •     The relationship between choosing the right product storage temperature and impact on product shelf life.
  •     Demystifying container closure requirements and storage temperature for various types of products.
  •     Performing an effective sampling plan and utilizing the appropriate sample size for a stability testing program.

Special Case Studies:
In a special closing session, Ms. Ogunsanya will dissect three warning letters detailing poorly designed stability testing programs.

Meet the Instructor:
Charity Ogunsanya, CEO of Pharmabiodevice Consulting LLC, has over 23 years of extensive experience within the pharmaceutical, biotechnology, biologics, cell-therapy, diagnostics, research and development, radio-pharmaceutical, contract manufacturing organization (CMO) and medical device companies.

Conference Details:
Designing and Sustaining Drug Stability Testing Programs:
How to Extend Product Shelf Life
**FDAnews Virtual Conference**
Sept. 30, 2014 — 10:00 a.m. – 4:00 p.m. EDT
http://www.fdanews.com/StabilityStudiesVC

Tuition:
$1,297 per site -- includes virtual conference registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/StabilityStudiesVC
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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