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Implement an Effective, Compliant Program that Ensures Efficacy, Safety and Product Survival

December 4-6, 2018
  • San Diego, CA

New Final Guidance Released!

On May 22nd FDA released a final guidance on Bioanalytical Method Validation. This guidance serves to inform the development of methods used to ensure the effectiveness for safety and effectiveness of drugs and biologic products. As stated in the documents, “Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

  • Does the method measure the intended analyte?
  • What is the variability associated with these measurements?
  • What is the range in measurements that provide reliable data?
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?”

Join us this December to discuss!

As the regulatory landscape shifts and drug approval processes continue to become more complex, now more than ever it is critical for life sciences companies to ensure sound stability testing standards to assess drug safety and efficacy. From reviewing core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing, IVT’s annual Stability Testing summit is the flagship event for stability professionals to convene in order to develop and hone your organization’s stability testing procedures.

Whether you are new to stability testing or a veteran stabilitarian, this event provides the ideal platform for scientists, chemists, quality control, laboratory and stability professionals to gain insight on the latest updates and challenges including off-label storage, change management, lean stability processes, comparability studies, risk analysis, stability chamber excursions, forced degradation and much more!

2018 Conference Highlights Include:

  • Develop, Implement and Maintain a Risk-Based Stability Program
  • Break down Regulatory Guidances for Data Integrity and Assess
    Impact on Stability Testing
  • Investigate OOT and OOS in Stability Studies
  • Implement Quality-by-Design (QbD) to Ensure Expected and
    Intended Performance
  • Overcome Stability Challenges of Short-Lived Compounds
  • Explore Combination Therapies Impact on Stability Methods
  • Assess Broadly Packaging and its Role in Stability
  • Discuss Moisture and Oxygen Control in Stability
  • Compare Stability Management in Manufacturing vs R&D Environments
  • Achieve Effective Stability Testing Processes in a Continuous
    Manufacturing Environment

Previous Attendee Acclaim:

This conference provided with excellent direction and advice that I can use and apply within my own organization.

QC Supervisor, Edgewell Personal Care

Great networking opportunity. Great information.
I learned many new things that I had not even considered
as part of my stability program.

Senior Research Associate, Alkermex

IVT consistently assembles the best Subject Matter Experts to address the latest challenges in the stability arena.

Principal Scientist, Genentech

Stability Testing

Implement an Effective, Compliant Program that Ensures Efficacy, Safety and Product Survival

New Final Guidance Released!

On May 22nd FDA released a final guidance on Bioanalytical Method Validation. This guidance serves to inform the development of methods used to ensure the effectiveness for safety and effectiveness of drugs and biologic products. As stated in the documents, “Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

  • Does the method measure the intended analyte?
  • What is the variability associated with these measurements?
  • What is the range in measurements that provide reliable data?
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?”

Join us this December to discuss!

As the regulatory landscape shifts and drug approval processes continue to become more complex, now more than ever it is critical for life sciences companies to ensure sound stability testing standards to assess drug safety and efficacy. From reviewing core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing, IVT’s annual Stability Testing summit is the flagship event for stability professionals to convene in order to develop and hone your organization’s stability testing procedures.

Whether you are new to stability testing or a veteran stabilitarian, this event provides the ideal platform for scientists, chemists, quality control, laboratory and stability professionals to gain insight on the latest updates and challenges including off-label storage, change management, lean stability processes, comparability studies, risk analysis, stability chamber excursions, forced degradation and much more!

2018 Conference Highlights Include:

  • Develop, Implement and Maintain a Risk-Based Stability Program
  • Break down Regulatory Guidances for Data Integrity and Assess
    Impact on Stability Testing
  • Investigate OOT and OOS in Stability Studies
  • Implement Quality-by-Design (QbD) to Ensure Expected and
    Intended Performance
  • Overcome Stability Challenges of Short-Lived Compounds
  • Explore Combination Therapies Impact on Stability Methods
  • Assess Broadly Packaging and its Role in Stability
  • Discuss Moisture and Oxygen Control in Stability
  • Compare Stability Management in Manufacturing vs R&D Environments
  • Achieve Effective Stability Testing Processes in a Continuous
    Manufacturing Environment

Previous Attendee Acclaim:

This conference provided with excellent direction and advice that I can use and apply within my own organization.

QC Supervisor, Edgewell Personal Care

Great networking opportunity. Great information.
I learned many new things that I had not even considered
as part of my stability program.

Senior Research Associate, Alkermex

IVT consistently assembles the best Subject Matter Experts to address the latest challenges in the stability arena.

Principal Scientist, Genentech