The time has never been greater to stay up-to-speed with current regulatory thinking. Join KENX for Laboratory University and stay up to date with the latest developments and regulations in Analytical Procedures & Methods Validation,Stability Testing & Program Management, and FDA Inspections of Quality Control Laboratories.
Stability testing is critical to the efficacy of drug substances. ICH, FDA, and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, the industry still has challenges to overcome and seeks more direction. Learn best practices to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators. Laboratory University takes participants through a best practice journey through the development, validation, transfer of analytical methods, stability testing and program management .
Analytical Procedures & Methods Validation:
• Develop a Customized Roadmap for Analytical Procedure Lifecycle Management
• Risk Based Tools for Development and Validation of Test Methods
• Managing Method Changes and Revalidation
• Successful Execution of Analytical Method Transfer
• Validation and Development of Stability Indicating Methods
• Develop an SOP and Master Plan for Method Validation
Stability Testing & Program Management:
• Stability Chambers Selection, Validation, and Calibration
• Stone Cold – Biologics, Tissue, Cell and Gene Therapy Stability Practices
• Program Development, Implementation and Management
• Staples of and Best Practices in Applying Stability Statistics
• Elements of Sample Control-Compliance, Inventory, and Tracking
• How Much Does a Stability Study Cost? Developing a Stability Financial Budget
FDA Inspections of Quality Control Laboratories:
• Conduct a Gap Analysis in the QC Laboratory
• Tips to Reduce and Handle Out of Specification (OOS) / Out of Trend (OOT) Test Results
• Validation and Qualification of Analytical Instruments, Equipment and Software Platforms
• Development, Implementation and Management of a Data Integrity Program
• Laboratory Management – Critical Elements, Effective Strategies, and Essential Tips for Process Control
Who Should Attend:
• Validation
• QA/QC
• Scientist
• Chemist
• Laboratory Management
• Regulatory Affairs
• Data Integrity
• Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
• Stability Laboratories
• Raw Materials
• Laboratory Management
• Regulatory Affairs
• Formulation
Speakers
David Deluca
Manager-Validation & Data Integrity at Compliance Group Inc
Shanna.M
Associate Director-Validation & Data Integrity Practice