Designing and Sustaining Drug Stability Testing Programs - Webinar CD/Transcript
Designing and Sustaining Drug Stability Testing Programs: How to Extend Product Shelf Life
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 your stability testing program wrong can result in significant wasted resources, delayed approvals and lost revenue.
For example, by miscalculating an expiration date you could remove product too early and reduce potential revenue or leave product on the shelf too long and impact patient health.
If the stability demons have you staying up at night, FDAnews and noted stability expert Charity Ogunsanya of Pharmabiodevice Consulting, have you covered.
In this 6-hour virtual conference CD and transcript set Ms. Ogunsanya provides 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 associated with the requirements of a product’s stability testing program.
- Delineating the program requirement specific to your type of product — it’s more confusing that you might think.
- Understanding the universe of new product stability indicator tests, and the rationale for choosing the right test and its impact on your product’s shelf life.
- The relationship between choosing the right product storage temperature and impact to its 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.
- Performing a compliant sample analysis, handling and effecting the appropriate test specification for the product type.
- How to conduct pre-approval and post approval stability testing studies
- Performing various types of stability tests such as reformulated products, accelerated temperature studies and others.
- Understanding the different types of stability test schedules provided by regulations.
Whether you're a drug, biologic, OTC, radio-pharmaceutical and combination product manufacturer, this virtual conference CD and transcript set will be a godsend. You don't have to face the difficulties with stability testing alone.
SPECIAL CASE STUDIES: Issues Encountered by Drug Product Manufacturers Based on a Poorly Designed Stability Testing Program
In a special closing session Ms. Ogunsanya will dissect three warning letters received by companies that ran afoul of the FDA. These will include:
- Failure to have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates [21 C.F.R. § 211.166(a)].
- Failure to have thoroughly investigated any unexplained discrepancy or the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192].
- Failure to ensure your container closure system provided adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product [21 C.F.R. § 211.94(b)].