Research and Markets has announced the addition of the “GMP Compliance for Quality Control and Contract Laboratories” conference to their offering.

This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls.

The program will also examine the impact of the benchmark court ruling in US versus Barr Laboratories on QC laboratory governance under GMP; the role of the QC Laboratory; its placement in the overall organizational structure of a company; the responsibility of a contract laboratory versus an in-house laboratory; regulatory requirements and expectations concerning the relationship between a contract laboratory and the company who gives the contract; the criticality of data integrity, with special emphasis on recent laboratory related issues that have arisen internationally, and case studies focusing on a review of common laboratory inspection observations.

Who Should Attend:

Laboratory scientists and managers
Quality Assurance professionals
Regulatory Affairs professionals
Compliance professionals
GMP Auditors
Anyone with management or oversight responsibility for QC Lab operations

Agenda:

Day 01 (8:30 AM – 4:30 PM)

Introductions and setting of attendees’ objectives – What do you want to get from this seminar?
Basics of FDA law and regulations for QC laboratories
What is CGMP and how does it apply to:
Laboratory Organization
Documentation and record-keeping requirements
Sample collection
Sample delivery, handling, disposition
Retain samples

Day 02 (8:30 AM – 4:30 PM)

Check in from day one: Compare topics covered to attendee objectives stated on day one
Stability (shelf-life) studies
Analytical method validation
Management and control of laboratory instruments
Management and control of laboratory supplies
Proper conduct of laboratory out of specification/out of trend investigations
Consequences of laboratory non-compliance – enforcement basics
Final Q&A and open discussion
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