Course Catalog

Methods Development, Validation Procedures, and Regulatory Compliance Issues

Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions.

Course Details

Key Topics

  • Highlights of the guidelines derived from international standards-ISO 9000 and ISO 17025, GLP, GMP, etc.
  • Conformity assessment – what it is, how it is applied.
  • Analytical method optimization during development.
  • Case studies in the improvement of validation characteristics.
  • Method development and optimization in HPLC and wet chemistry.
  • ICH, AOAC, and USP guidelines for methods validation and other standards.
  • Regulatory submission packages for IND, NDA, ANDA and other phases of development.

Information

Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions. Key topics covered include: conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more.

Who Should Attend

Scientists, managers, and technicians involved in methods development and optimization, analytical research and development, meeting FDA requirements and regulations, validating analytical methods, application of newer analytical methods, and those involved in quality control, quality assurance, and quality assessment.

Benefits

  • Increase your knowledge of conformity assessment, quality control and quality assurance.
  • Consult with a knowledgeable instructor about your current technical problems and preparation and requirements for submission of regulatory packages (NDA, ANDA, IND, MMA and others for FDA & OECD).
  • Learn a generic approach for developing an analytical method and optimizing it.
  • Become acquainted with practical approaches for validating new analytical procedures.
  • Familiarize yourself with methods development and optimization in HPLC.
  • Be exposed to the latest international requirements and guidelines: ICH, ISO 17025, OECD, & FDA guidelines for analytical validation.
  • Learn about the FDA’s new initiatives in systems-based inspection and risk-based assessment.
  • Understand the training and supervision requirements of chemists and technicians and other lab personnel for GLP.
  • Receive helpful hints to help prepare you for a visit from an auditor’s perspective.
  • Participate in discussions on cGMP, GLP, WHO and OECD requirements and expectations.
  • Learn about general validation and qualification requirements for analytical instruments such as HPLC, TOC, CE, LC-MS, AA, UC/VIS, Dissolution and other emerging techniques.

Agenda

  • Fundamentals – Quality, Quality Control, and Quality Assurance, general discussions on quality, QC, QA, and guidance from domestic and international standards; definitions and descriptions of validation parameters; principles of method validation, conformity assessment and laboratory QA.
  • Method Validation – Guidelines Derived from GLP, AOAC, ISO 9000, and ICH, examples of development and optimization of methods ab initio and development of validation criteria; definition of ruggedness, reproducibility, system suitability, precision, accuracy, LOD, LOQ and other validation parameters for FDA compliance.
  • Method Development and Optimization by Example and Case Studies – How to systematically develop and optimize an assay for a trace component in a very complex sample matrix.
  • Method Development and Optimization in HPLC as an Example of a Current Analytical Techniques – Aspects of HPLC that need to be developed, and optimized, including procedures; peak purity, spectral match, peak tailing and other considerations in HPLC.
  • Methods Optimization Considerations in Spectroscopic (UV-VIS, AA) and Classical Techniques – Statistical treatment of data: practical examples and case studies.
  • Statistical Treatment of Analytical Data – Mean, Mode, Standard Deviation, Control Charts, etc.
  • Statistical Process Control (SPC) Applications for Process Improvement and Process Optimization

Course Locations

Date

June 19 - 20, 2017

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 Online Register Via Mail

Venue

MicroTek
230 West Monroe Street Suite 900
Chicago, IL 60606


Pricing
  Member Non-Member
Advanced $1,495 (Ends May 19) $1,695 (Ends May 19)
Standard $1,895 $2,095

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, mail or phone and mention this discount and may not be combined with any other offer.

Date

August 19 - 20, 2017

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 Online Register Via Mail

Venue

TBA

Washington, DC 20036


Pricing
  Member Non-Member
Advanced $1,495 (Ends July 19) $1,695 (Ends July 19)
Standard $1,895 $2,095

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, mail or phone and mention this discount and may not be combined with any other offer.

Date

November 8 - 9, 2017

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 Online Register Via Mail

Venue

MicroTek
350 10th Avenue Suite 950
San Diego, CA 92101


Pricing
  Member Non-Member
Advanced $1,495 (Ends October 6) $1,695 (Ends October 6)
Standard $1,895 $2,095

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, mail or phone and mention this discount and may not be combined with any other offer.

About the Instructor

  • Shib Mookherjea

    is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management.