Course Catalog

Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ)

Understand the process for design, installation, operation and performance (DQ, IQ, OQ, PQ) in the analytical laboratory. Learn what regulatory and quality systems requirements are for compliance and conformity, how to implement qualification and validation systems and keep them current to meet business needs, how to perform necessary maintenance through PM, and how to adapt your current GLP system to meet changing requirements.

Course Details

Key Topics

  • What the regulatory (cGMP, GLP) and quality systems (e.g., ISO-9001, ISO-17025) requirements are for compliance and conformity.
  • How to implement qualification and validation systems and keep them current to meet business needs.
  • How to perform necessary maintenance through PM.
  • How to adapt your current GLP system to meet changing requirements.

Information

Understand the process for design, installation, operation and performance (DQ, IQ, OQ, PQ) in the analytical laboratory. Learn what regulatory and quality systems requirements are for compliance and conformity, how to implement qualification and validation systems and keep them current to meet business needs, how to perform necessary maintenance through PM, and how to adapt your current GLP system to meet changing requirements.

Who Should Attend

Managers and supervisors of chemical analytical laboratories; chemists who collect, analyze, process, or maintain laboratory data for submission to the EPA, FDA, or other regulatory agencies; and chemical scientists involved in quality control or quality assurance in labs that support cGMP, GLP, and other manufacturing operations.

Benefits

  • Consult with a recognized expert about your qualification and validation problems and concerns.
  • Learn about the FDA?s new initiatives in systems based inspection.
  • Understand the training and supervision requirements of chemists and technicians.
  • Receive helpful hints to help you prepare for a visit from an auditor.
  • Participate in discussions on cGMO, GLP, WHO, OECD requirements and expectations.

Agenda

  • The Product Lifecycle Concept.
  • Quality Control (QC), Quality Assurance (QA) Roles vis-à-vis Validation Process.
  • FDA?s New Initiatives in Systems Based Inspection.
  • ISO-17025, ISO-9001-2000 and Other International Quality Systems (QS) and Guidelines.
  • Master Validation Plan and Documentation.
  • Training and Awareness.
  • Insight into a Generic Approach to Validation.
  • Discussions on cGMP, GLP, WHO, and OECD Requirements and Expectations.
  • General QA Expectations in Analytical and Microbiological Laboratories.

Course Locations

Date

TBA

Check-in opens at 7:30 a.m.

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

Register Online Register Via Mail

Venue

TBA


Pricing
Advanced $550
Standard $850

The course fee includes a course binder and a continental breakfast

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.

About the Instructor

  • Shib Mookherjea

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