Course Catalog

Introduction to GLP Regulations and Bioanalytical Method Validation by LC/MS/MS

GUIDANCE FOR INDUSTRY/Bioanalytical Method Validation represents the Food
and Drug Administration’s current thinking on this topic and was published in May 2001. Since then, almost all regulated bioanalytical methods have been validated based on the guidance even though it does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation. This guidance also applies to bioanalytical methods used for non-human pharmacology/toxicology studies and preclinical studies.
For studies related to the veterinary drug approval process, this guidance applies only to blood and urine BA, BE, and PK studies.

This one-day short course will focus on the bioanalytical method validation to quantify drugs in biological matrices using LC/MS/MS. To help audiences comply with FDA’s regulations, Good Laboratory Practice (GLP) and its role in the pharmaceutical industry will be discussed in details.

Course Details

Key Topics

  • Overview of FDA and history of GLP Guidelines
  • Introduction to Regulation and Guidance
  • GLP requirements
  • GLP Inspection & Enforcement
  • Bioanalytical Method Validation for Drug by LC/MS/MS
  • Special topics: Matrix Effects on MS; Urine Samples; Dried Blood Spot Analysis

Information

GUIDANCE FOR INDUSTRY/Bioanalytical Method Validation represents the Food
and Drug Administration’s current thinking on this topic and was published in May 2001. Since then, almost all regulated bioanalytical methods have been validated based on the guidance even though it does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation. This guidance also applies to bioanalytical methods used for non-human pharmacology/toxicology studies and preclinical studies.
For studies related to the veterinary drug approval process, this guidance applies only to blood and urine BA, BE, and PK studies.

This one-day short course will focus on the bioanalytical method validation to quantify drugs in biological matrices using LC/MS/MS. To help audiences comply with FDA’s regulations, Good Laboratory Practice (GLP) and its role in the pharmaceutical industry will be discussed in details.

Who Should Attend

Scientists, technologists, and engineers in the pharmaceutical industry, regulatory affairs, quality control, and quality assurance. Chemists working in the GLP-regulated labs, lab supervisors and managers, QA managers and personnel, GLP auditors and CRO consultants, who need a fundamental understanding of GLP and guidance.

This course also is useful to all levels of management as a refresher course to stay current with GLP regulations.

Agenda

  • Introduction
    • Food, Drug, and Cosmetic Act (FDC)
    • Good Manufacturing Practice (GMP)
    • Good Laboratory Practice (GLP)
    • GXP
    • History of FDA and Its Role
  • Good Laboratory Practice
    • History of GLP Regulations
    • Specifications of GLP-Type Work
    • The Key Requirements for GLP-Type Work
    • GLP Requirements for Personnel
    • GLP Requirements for Study Director and QAU
    • Facility and Equipment Requirements
    • Hot to Conducting a GLP Study
    • GLP Inspection & Enforcement
    • Form 483 and Warning Letter
  • Guidance and Bioanalytical Method Validation by LC/MS/MS
    • Role of the Guidance
    • Validation Process
    • Validation Plan
    • Validation Document
    • Validation Bottleneck or Challenges
    • Different Validations (Full-, Partial- and Cross Validation) and Their
      Applicability
  • White Paper Discussion

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the first day of the course.

Course runs from 8:30 a.m. to 5:00 p.m. each day.

Register Via Mail

Venue

TBA

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
Early $550
Standard $850

About the Instructor

  • Dr. Perry G. Wang

    is a chemist in the Office of Regulatory Science, US Food and Drug
    Administration (US FDA). His interests include analytical method development and validation for drugs and constituents of foods and cosmetic products using advanced instrumentation. His expertise focuses on high throughput drug analysis by LC/MS/MS for the pharmaceutical industry.