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Analytical Instrument Qualification and System Validation :2-Day In-Person Seminar

ComplianceOnline

Thursday, February 6, 2020 at 8:30 AM - Friday, February 7, 2020 at 4:30 PM (PST)

Analytical Instrument Qualification and System...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (USD)(Early bird price)   more info Oct 30, 2019 $1,899.00 $0.00
Seminar One Registration (USD) Feb 6, 2020 $2,099.00 $0.00

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Event Details

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.

This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

Learning Objectives:

  • Learn about the regulatory background and requirements for equipment qualification according to USP and computer system validation according to GAMP 5
  • Be able to explain the difference between equipment calibration, qualification and system validation
  • Learn which equipment/systems need to be qualified or validated
  • Be able to allocate equipment and systems to USP and GAMP 5 categories and to design and execute qualification/validation protocols accordingly
  • Understand the logic and principles of instrument qualification and system validation from planning to reporting
  • Be able to develop a qualification and validation strategy
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate regulatory compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation
  • Learn how to ensure, document and audit the integrity of GMP records

Who will Benefit:

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants

Speaker:

Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

 
 

 

For Registration - https://www.complianceonline.com/analytical-instrument-qualification-computer-system-validation-seminar-training-80617SEM-prdsm?channel=eventbrite         

 

Note: Use coupon code  REFERRAL10  and get 10% off on registration.

Have questions about Analytical Instrument Qualification and System Validation :2-Day In-Person Seminar? Contact ComplianceOnline

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When & Where


San Francisco
Venue to be announced shortly
San Francisco, CA 94016

Thursday, February 6, 2020 at 8:30 AM - Friday, February 7, 2020 at 4:30 PM (PST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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