Designing and Sustaining Drug Stability Testing Programs

Designing and Sustaining Drug Stability Testing Programs - Webinar CD/Transcript

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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)].
  • Chemistry, Manufacturing, and Controls (CMC)
  • Quality assurance/quality control
  • Operations
  • Materials management
  • Purchasing
  • Closure design and Packaging
  • Plant engineering
  • In-bound testing and certification
  • Product lifecycle management
  • Regulatory affairs

Meet Your 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.  Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the quality and compliance division in major fortune 100 companies both as a subject matter expert (SME), site manager, multi-site manager and director levels receptively.  Her technical expertise are not limited to the interpretation, administration and set up of manufacturing operations, quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, regulatory affairs, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.