ANALYTICAL METHOD VALIDATION & Laboratory Data Integrity Compliance

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Life Cycle Management of Methods, Procedures and Data Governance

May 15 - May 17

San Diego, United States

Recent FDA Warning Letters Highlight Laboratory Procedures and Data Integrity Deficiencies

 

In 2017, FDA has issued many Warning Letters emphasizing CSV non-compliance. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant analytical procedures. KENX is pleased to announce that our comprehensive AMV & DI Congress is headed to San Diego and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

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

 

Data Integrity Compliance

  • 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

  • 1:15
    Chairperson’s Opening Remarks
  • 1:30
    FDA’s Data Integrity Guidance, Trends and Warning Letters
  • 2:15
    FDA Warning Letter Trends in Analytical Procedures and Methods Validation
  • 3:30
    Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science Industry
  • 4:15
    Impact of Human Factors on Data Integrity in the Laboratory
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • (2)
    Audit Your Audit Trails
  • 08:30 – 12:00
    Select Between Knowledge Exchange Workshops (A-B)
  • (A)
    Ensure Data Integrity in the Face of the Modern Threat Landscape
  • (B)
    Development and Validation of a Stability-Indicating Analytical Method
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions (4-6)
  • (4)
    Define and Develop the Content and Scope of Analytical Procedures Program
  • (5)
    Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • (6)
    Identify and Handle the Root Cause of a Laboratory Data Integrity Breach
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (7-8)
  • (7)
    Develop a Roadmap for Analytical Methods Validation
  • (8)
    Preparing for and Performing a Laboratory Data Integrity Audit
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (9-11)
  • (9)
    Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • (10)
    Maintaining Data and Metadata Integrity for Records Retention Workflows
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (12-14)
  • (12)
    Handling of Analytical Procedure Variation
  • (13)
    Advanced Lab Professional Master Class
  • (14)
    Understand and Prevent Behavioral Non-Compliance
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (15-17)
  • (15)
    Evaluate Characteristics through Statistical Analysis of Validation Data
  • (16)
    Learn How to Perform Analytical Risk-Based Evaluations
  • (17)
    Ensure the Reliability and Completeness of Analytical Data
  • 1:00 – 2:30
    Select Between Knowledge Exchange Sessions (18-19)
  • (18)
    Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • (19)
    Handle the FDA Laboratory Methods Verification Process
  • 3:00 – 4:30
    Select Between Knowledge Exchange Sessions (20-22)
  • (20)
    Effectively Manage Protocols for Method Transfer Studies
  • (21)
    Develop a Continued Verification Program in the Analytical Laboratory
  • (22)
    Perform a Risk Assessment for Data Deficiencies

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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