STABILITY TESTING & Program Management

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Implement Best-In-Class Procedures through the Product Life Cycle

May 15 - May 17

San Diego, United States

Stability Testing & Program Management Excellence

 

Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. The time has never been more critical to evaluate your program  and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators. . KENX is pleased to announce that our comprehensive Stability Testing & Program Management is headed to San Diego to showcase programs and procedures that excel and avoid regulatory action.

 

Stability Leaders Showcase Best-In-Class Programs

 

  • Develop and Validate Stability-Indicating Analytical Methods
  • Learn How to Perform Risk-Based Stability Testing
  • Walk through a Case Study for Stability Testing of New Drug Substances and Products
  • Establish Change Control Procedures for Stability Programs
  • OOS/OOT – Learn How to Handle Testing Variation
  • eStability – Automate Drug Stability Reporting Validation Procedures
  • Use Container Closer System Integrity Testing as a Stability Protocol
  • Apply Bracketing and Matrixing Designs for Testing
  • Evaluate overall Photosensitivity through Forced Degradation Testing Studies
  • Biologic Case Study – Establish Testing Limits for Standardized Grass Pollen Extracts
  • Discover the Most Effective Approach for Evaluating Stability Data
  • Stability Data Integrity – Implement a Governance Program
  • Manage Storage Conditions in Zones III and IV
  • Predict Shelf Life through Accelerated Testing
  • FDA Inspections – Prepare for an FDA Audit
  • Case Study – Implement a Stability Program for Medical Device Manufacturing

 

Personnel in the Following Environments Should Attend:

  • Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
  • QA/QC
  • Stability Laboratories
  • Raw Materials
  • Laboratory Management
  • Regulatory Affairs
  • Forumulation

This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection and statistics.

Agenda

  • 1:00
    Chairperson’s Opening Remarks
  • 1:15
    The Interrelationship between FDA, ICH and WHO Regulations
  • 1:55
    Stability Data Integrity - Implement a Governance Program
  • 2:35
    Impact of Human Factors in the Stability Laboratory
  • 3:35
    OOS/OOT - Learn How to Handle Testing Variation
  • 4:15
    FDA Inspections - Prepare for an FDA Audit
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Learn How to Perform Risk-Based Stability Testing
  • (2)
    Case Study - Implement a Stability Program for Medical Device Manufacturing
  • 08:30 – 12:00
    Select Between Knowledge Exchange Workshops (A-B)
  • (A)
    Walk through a Case Study for Stability Testing of New Drug Substances and Products
  • (B)
    Development and Validation of a Stability-Indicating Analytical Method
  • 1:15 – 2:45
    Knowledge Exchange Session
  • (3)
    Establish Change Control Procedures for Stability Programs
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (5-6)
  • (5)
    OOS/OOT - Learn How to Handle Testing Variation
  • (6)
    Use Container Closer System Integrity Testing as a Stability Protocol
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (7-8)
  • (7)
    Apply Bracketing and Matrixing Designs for Testing
  • (8)
    Evaluate Overall Photosensitivity through Forced Degradation Testing Studies
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (9-10)
  • (9)
    Biologic Case Study - Establish Testing Limits for Standardized Grass Pollen Extracts
  • (10)
    Discover the Most Effective Approach for Evaluating Stability Data
  • 10:30 – 12:00
    Knowledge Exchange Session (11)
  • (11)
    Learn How to Perform Risk-Based Stability Testing
  • 1:00 – 2:30
    Select Between Knowledge Exchange Sessions (13-14)
  • (13)
    Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • (14)
    Discover the Most Effective Approach for Evaluating Stability Data
  • 3:00 – 4:30
    Knowledge Exchange Session (15)
  • (15)
    Predict Shelf Life through Accelerated Testing

Faculty

    More Information To Follow Soon

Sponsors

Partners

Venue

Details

Start:
May 15
End:
May 17
Event Category:

Venue

The Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(858) 488-0551
Website:
http://bahiahotel.com/

Pricing & Registration

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