Life Science Stability Testing and Validation Conference

March 19-20, 2018 | Herndon, VA

Hilton Washington Dulles Airport Hotel

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DAY TWO | TUESDAY, MARCH 20

8:30 REGISTRATION AND MORNING COFFEE

9:00 FDA AUDIT EXPECTATIONS FOR STABILITY TESTING AND VALIDATION

  • Justifying scaled down stability containers for audits
  • Storage facility audit and review expectations
    • Inventory management
    • Handling of stability chambers
    • Chamber backup strategies
  • Assessing data integrity of stability testing programs
    • Accurate and untampered data
    • Real time statistics
  • Auditor review of statistical analysis of data trends
  • Expanded Interpretations of regulations and individual auditor preference

Emily S. D. Trubee, MS, Stability Manager, ADARE PHARMACEUTICALS

 

9:45 STABILITY REPORTS FOR SUBMISSION TO FDA REGULATORY AUTHORITIES

  • FDA documentation expectations
    • FDA data & documentation expectations
    • Rapid stability studies
    • Stress degradation attributes
    • Post-approval changes
  • Differences in small molecule and large molecule filings
  • FDA findings at difference phases
  • Impact assessments of temperature and humidity excursions

Joshua Ayers, Stability Manager, ZS PHARMA

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 CASE STUDY: NAVIGATING STABILITY STRATEGIES TO SUPPORT POST-APPROVAL CHANGES
As stability testing is involved throughout an entire product lifecycle, including post-approval, any changes made in drug formulation, manufacturing or packaging post-approval need review to determine the changes effect on the drug stability, requiring additional stability testing and documentation to support the changes. Specific stability testing and data is required for submission in various reports depending on the complexity of the change, which requires stability departments to have a clear understanding of regulatory expectations and requirements. Examining post-approval change scenarios, attendees will be given the chance to discuss submission strategies and analyze best practice for future post-approval changes.

  • Requirements to support Major versus Minor changes
  • Post-approval regulatory requirements
  • Discuss and analyze post-approval change scenarios

Sally Wong, Vaccines & Biological Stability, MERCK & CO.

 

11:45 GROUP DISCUSSION: STABILITY STRATEGIES FOR POST APPROVAL CHANGES
Groups will discuss post-approval changes specific to areas of interest including:

Group 1: Small molecule
Josh Ayers, ZS PHARMA

Group 2: Large molecule
Sally Wong, MERCK & CO.

Group 3: Combination product
Jian Liu, ABBOTT VASCULAR

 

 

12:15 LUNCHEON FOR ALL CONFERENCE GUESTS

 

1:30 STABILITY DATA EVALUATION TO SUPPORT THE DISTRIBUTION OF MEDICINAL PRODUCTS
The objective of this session is to describe and justify studies using scientific data and rationale in support of the distribution of product through the supply chain to the end user. The conditions of transport for medicinal products must be appropriate to maintain the quality of the product. Consideration must be given to assuring protection against exposure to unacceptable environmental conditions that may impact the stability attributes of the product. Balancing prescriptive guidance afforded by the product label with the risks associated with the excursions that may result through the distribution of the product to the end user may require a comprehensive review of risk resulting in the budgeting stability data.

  • Navigate regulatory expectations regarding product label and support for distribution excursions
  • Design of stability studies, excursion studies, and temperature cycling studies to support product distribution through the supply chain to the end user
  • Stability budgeting
  • Supply chain risk and mapping
  • Label storage interpretation

Joseph Zelhof, Director, Global Pharmaceutical Quality Stability, BRISTOL-MYERS SQUIBB

 

 

2:15 CREATING EFFECTIVE FRAMEWORKS FOR STABILITY TEST OUTSOURCING IN THE LIFE SCIENCES INDUSTRY
Outsourcing drug stability testing and validation is a common, but challenging process for manufactures in the pharmaceutical and biotechnology industry, helping organizations save valuable time and resources through decreasing overheads resulting from in-house testing methods. While there are several benefits that come from outsourcing stability testing, manufactures require stronger and more effective frameworks to eliminate outsourcing operation concerns such as cross contamination, complying with quality standards and sharing of intellectual data. Further, statistical analysis of test results must be collected and formatted in such a way that allows for results to be easily integrated and aggregated into existing frameworks to reduce duplicate work and ensure ease of analysis internally.

  • Building strong frameworks for outsourcing partnerships
  • Implementing early standards to prevent operational error
  • Risk management and analysis for recurrent partnerships

Bette Monnot-Chase, Director, CMC & Quality, ASKLEPION PHARMACEUTICALS

 

3:00 PANEL: ALIGNING STABILITY TESTING GOALS WITH R&D, CLINICAL, REGULATORY & QUALITY
Stability testing plays an important role throughout the product lifecycle, impacting the development of products, regulatory clearance, post-market quality assurance and annual regulatory reporting for approved products, and as such, must align projects and goals alongside various departments to unite operating procedures. In order to meet the deadlines of varied departments and ensure products do not face delays in development or production, stability testing teams must balance a wide range of priorities and goals. Successful groups work in a unified manner, connecting projects across business units to meet increasingly rapid development timelines.

  • Early partnerships between stability and R&D teams
  • Evolving stability testing throughout clinical testing
  • Connecting stability testing to post-market regulation

Emily S. D. Trubee, ADARE PHARMACEUTICALS

Bette Monnot-Chase, ASKLEPION PHARMACEUTICALS

Madhavi Mahavadi, BAYER

 

3:45 CLOSING REMARKS & PROGRAM CONCLUSION