Validation of Bioanalytical Assays for Biologicals
Instructor:
Ana Menendez
Product ID: 700214
Training Level: Intermediate
- Duration: 75 Min
Why Should You Attend:
Strategic management of the pharmacokinetic profile of a drug is a critical determinant of therapeutic success in the clinic. Successful development and validation of the bioanalytical assays that support these studies are key components to the process. This presentation describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews and compares current regulatory and industry guidelines with a goal to preparing a compliant validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls and suggests solutions
Areas Covered in the Seminar:- Expectations of the GLP (GCLP) environment.
- Effective assay development.
- Maximizing precision and accuracy.
- Minimizing matrix effects.
- Setting specifications for the validation protocol.
- Sample re-analysis plan.
- Managing the life cycle of the bioanalytical assay.
- Bioanalytical scientists
- Pharmacokinetic specialists
- Biotech R&D staff
- Clinical research associates
- Validation specialists
- Project Management
- Regulatory staff
- QA/QC
- Outsourcing Professionals
- Biopharmaceutical Consultants
Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular molecular and immunological procedures. Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.
Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.
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