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Common Problems and Mistakes in Method Validation in Drug Development Process  

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Online Compliance Panel   

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Pharmaceuticals, biopharmaceuticals and dietary supplements professionals

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


Common Problems and Mistakes in Method Validation in Drug Development Process Webinar

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

Who will Benefit

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

Seminar Summary:

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. (see full course description)

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