2 Day Virtual Analytical Instrument Qualification and System Validation Course: August 16-17, 2022
DUBLIN, Aug. 2, 2022 /PRNewswire/ -- Final days to register for the "Analytical Instrument Qualification and System Validation" training course that has been added to ResearchAndMarkets.com's offering.
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.
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.
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.
Who Should Attend:
Key Topics Covered:
11:30 AM - 11:45 AM - Break
12:45 PM - 1:15 PM - Lunch
2.30 PM - 3.15 PM - Equipment Maintenance and Change control
3.15 PM - 4.00 PM: Type and extend of qualification for USP Instrument Categories
4:00 PM - 4:15 PM - Break
Day 02 (10:00 AM - 5:00 PM EDT)
11:00 AM - 11:15 AM - Break
12.15 PM - 1.00 PM - Periodic revalidation of chromatography data systems
1:00 PM - 1:45 PM - Lunch
2.30 PM - 3.00 PM - Ensuring Integrity and Security of GMP data
3:00 PM - 3:15 PM - Break
4.30 PM - 5.00 PM - Wrap up - Final questions and answers
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.
Research and Markets
For E.S.T Office Hours Call +1-917-300-0470
U.S. Fax: 646-607-1907
SOURCE Research and Markets