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Validation of Analytical Methods and Procedures Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Instructors:
Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since
Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
many years.
Good Documentation Practices for Laboratory Operations Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. ..more
Auditing Systems for 21CFR Part 11 Compliance Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies.
Kerry Paul Potter President, Summit Consulting, Inc.
Risk-Based Validation of cGMP Systems
This presentation will review a methodology for implementing RiskBased Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.
Analytical Instrument and Equipment Qualification in Quality Laboratories The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials.
Calibration and Qualification in Analytical Laboratories Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections.
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. ..more
Richard Poser President, First Quality Inc
Richard Poser, PhD is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers,..more
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation Complying with GLP regulations can increase the cost of a
Your Necessity is our Priority
laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations.
Click here to buy the webinar pack It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
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