Common Problems and Mistakes in Method Validation in Drug Development Process

Common Problems and Mistakes in Method Validation in Drug Development Process is organized by OnlineCompliancePanel and would be held on Jul 12, 2017.

The target audience for this medical event for Pharmaceuticals, biopharmaceuticals and dietary supplements professionals including:
• Method development scientists
• Method validation scientists
• Quality control professionals
• Quality assurance professionals
• Manufacturing professionals
• Laboratory managers
• Auditors
• Research and development
• Regulatory Affairs professionals

Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue. Setting appropriate acceptance criteria based on data from final development and qualification is important for assay performance in the validation. This webinar will address issues that arise during development and validation that lead to failure and rework. The webinar also includes approaches to validation that can prevent failure and increase successful completion of validation.

Objectives of the Presentation
• Why method development is critical for a good method validation
• Importance of understanding trends and outliers
• Appropriate handling and setting of specifications for reagents and samples
• Importance of pre-validation (qualification) data
• Implementing good training procedures
• Defining the validation process
• Learning from failures

Why Should you Attend
Validation rework is costly and impacts timelines negatively. Properly preparing for validation contributes to successful, on time completion of method validations. This webinar provides information that will assist attendees with identifying and correcting common issues that may arise during validation of methods required in drug development. Issues revolving around lack of supporting data for validation acceptance criteria, lack of analyst training, and not testing specific parameters during development will be addressed. Attendees should gain knowledge to help resolve potential issues that may arise during validation.

Areas Covered
• Defining the method selected for development
• Certifying the reference standard
• Setting appropriate limits for reagents
• Reagent supply and sample handling
• Testing robustness/ruggedness/selectivity/specificity prior to validation
• Analyst training
• Peer review of the test method
• Validation protocol and templates
• Preplanning
• Documentation of deviations and failures

Note: Use Promo code CG6KF and get 10% off on registration (Valid till JULY 31st 2017)

Additional details will be posted as soon as they are available.