Validation of Bioanalytical Assays for Biologicals

Instructor: Ana Menendez
Product ID: 700214
Training Level: Intermediate
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2011

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.

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.
Who Will Benefit:
  • Bioanalytical scientists
  • Pharmacokinetic specialists
  • Biotech R&D staff
  • Clinical research associates
  • Validation specialists
  • Project Management
  • Regulatory staff
  • QA/QC
  • Outsourcing Professionals
  • Biopharmaceutical Consultants

Instructor Profile:

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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