LABORATORY MANAGEMENT & QC EXCELLENCE

Between FDA’s interest in releasing guidance’s on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation, global regulatory updates on Data Integrity, and OOS investigations, the time has never been more critical for you and your company to receive the training you need to maintain compliance and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and has become the backbone of product lifecycle management; however, each agency has respective guidance and left much for interpretation. This conference takes participants through a journey of managing laboratories, regulatory trends, best practice implementation, analytical method profiles and innovative technology. Attend this event and meet industry’s leading scientists as they share their experiences on how analytical procedures are developed and validated, and how data is evaluated leading to critical business decisions.

Choose From Over 35 Tutorials Addressing Today’s Top Challenges 

Analytical Procedures and Methods Validation Highlights Include:

  • Documentation and Revalidation Strategies after Method Changes
  • USP General Chapter <1220> Overview and Implementation Roadmap
  • Assay Transfer, Qualification, Validation – Are We Living in a ‘Land of Confusion’?
  • Analytical Method Development Using QbD
  • Validation of the Stability-Indicating Profile of a Biological Product
  • Equipment considerations when executing Analytical Method Transfer
  • Monitoring organic impurities: the dynamic impact of USP General Chapters <476>, <477>, and <1086>
  • Forced Degradation and Stress Study to Support Specificity in Validation
  • Uncertainty of Equipment when Developing Analytical Method
  • Analytical Instrument Qualification to Support Method Lifecycle
  • QC Lab Data Integrity Programs – Development, Implementation and Maintenance

Lab Management and QC Excellence Highlights Include:

  • FDA’s New Update of OOS Guidance (05/2022) – What It Means for You
  • Reducing and Handling Out of Specification (OOS) / Out of Trend (OOT) Test Results
  • Identify Root Cause and Implement Corrective Action
  • Effective Laboratory Workflows to Improve Efficiency and Productivity
  • How to Graph and Analyze Data for Decision Making
  • Set and Evaluate the Performance of Specifications
  • Discover Common Issues Typically Found with Instrument Qualification
  • Data Integrity Process Mapping – Identify and Mitigate Data Gaps
  • Establish a Program for Laboratory Disaster Prevention
  • Uncover the Cost of Human Errors and How it Impacts Laboratory Management
  • Laboratory Records and Notebooks – Compare Notebooks, Worksheets, and Records for Accuracy

PLUS! This event is co-located with Stability Testing and Program Management.

Click HERE to view the Stability Testing and Program Management Event Page

Personnel in the Following Areas 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.


EARLY BIRD PRICING ENDS MARCH 31!

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - STABILITY TESTING & PROGRAM MANAGEMENT EXCELLENCE2023
$ 2,595.00 $2,595.00
Unlimited
Team Discount - Register 3 with 4th Free - STABILITY TESTING & PROGRAM MANAGEMENT EXCELLENCE 2023
$ 2,595.00 $ 1,946.25 $1,946.25
Unlimited
Temple Track - STABILITY TESTING & PROGRAM MANAGEMENT EXCELLENCE 2023
$ 2,595.00 $2,595.00
Unlimited

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.


Who 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.



Faculty