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Press Release

Two Day Program: GMP Compliance for Quality Control and Contract Laboratories - Hayward, CA, United States - December 1-2, 2016 - Research and Markets

Research and Markets
Posted on: 09 Nov 16

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

For more information about this conference visit http://www.researchandmarkets.com/research/hf79vg/gmp_compliance

View source version on businesswire.com: http://www.businesswire.com/news/home/20161109006150/en/

Business Wire
www.businesswire.com

Last updated on: 09/11/2016

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