loader
 

ANALYTICAL PROCEDURES & METHODS VALIDATION

Loading Events

« All Events

Develop, Implement and Maintain Processes that Survive the Product Life Cycle

June 22, 2020 - June 24, 2020

San Diego, United States

Analytical Procedures & Methods Validation

 

The time has never been greater to stay up-to-speed with current regulatory thinking. Between FDA’s interest in releasing guidance’s the last few years on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures and generate data and information that lead to critical business decisions. This conference takes participants through a best practice journey through the development, validation and transfer of analytical methods

 

Choose from Over 25 Tutorials Addressing Today’s Top Analytical Challenges

 

Analytical Procedures and Methods Validation Highlights Include:

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

 

Maximize Your Training! Laboratory Data Integrity Compliance Congress Highlights Include:

  • Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
  • Conduct a GAP Analysis and Identify Root Causes
  • Conduct an Laboratory DI Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Discover the Impact of Human Behavior
  • Implement Risk Management Protocols, Perform Assessments and Continually Verify
  • Prepare for and Handle FDA DI Investigations
  • Understand Requirements and Handle Audit Trail Reviews

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity

 

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.

 

For an additional $995, you can earn 1.5 graduate credit hours towards Temple’s RAQA Graduate Program! For more information on the Temple Track for Lab University, email info@kenx.org, or call 856-281-7134.

 

CLICK HERE FOR A SNEAK PEAK AT THE AGENDA

Agenda

More Information To Follow Soon

Faculty

    More Information To Follow Soon

Sponsors

    More Information To Follow Soon

Partners

    More Information To Follow Soon

Venue

Details

Start:
June 22, 2020
End:
June 24, 2020
Event Category:
Website:
https://www.kenx.org/events/lab-data-integrity-2019/

Venue

San Diego, CA
San Diego, CA 92109 United States + Google Map

Pricing & Registration

opt-in below for event updates