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ANALYTICAL PROCEDURES & METHODS VALIDATION

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

June 17, 2019 - June 19, 2019

Philadelphia, United States

Analytical Procedures & Methods Validation

 

The time has never been greater to stay up-to-speed with current regulatory thinking. Between FDA’s newly released guidance on Bioanalytical Method Validation and the 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 20 Tutorials Addressing Today’s Top Analytical Challenges

 

Analytical Procedures and Methods Validation

  • 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

 

This Conference is Co-located with Laboratory Data Integrity Congress!

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Laboratory Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Cybersecurity Risk Management Implementation and Continued Verification
  • Perform a Risk Assessment for  Data Deficiencies
  • Understand Requirements and How to Handle Laboratory Audit Trails

 

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.

Agenda

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Venue

Details

Start:
June 17, 2019
End:
June 19, 2019
Event Category:
Website:
https://www.kenx.org/events/analytical-validation/

Venue

Wyndham Philadelphia
400 Arch Street
Philadelphia, PA 19106 United States
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Phone:
(215) 923-8660
Website:
https://book.passkey.com/e/49825646

Pricing & Registration

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