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.
Learn about the regulatory background and requirements for equipment qualification according to USP
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
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 Should Attend:
IT/IS managers and system administrators
QA managers and personnel
Laboratory managers and supervisors
Key Topics Covered:
Day 01 (10:00 AM – 5:00 PM EDT)
10.00 AM – 10.45 AM – Requirements and approaches for Analytical Instrument Qualification
FDA/EU, PIC/S requirements
Qualification/calibration issues in FDA inspections
USP General Chapter
The instrument qualification lifecycle
Prioritizing calibration/qualification activities
10.45 AM – 11.30 AM – Qualification in Practice
User requirement specifications
Preparing inspection-ready documentation
11:30 AM – 11:45 AM – Break
11.45 AM – 12.45 PM – Testing and deviation handling
Developing test protocols
Documenting test evidence
Review and approval of test results
12:45 PM – 1:15 PM – Lunch
1.15 PM – 2.30 PM – Retrospective qualification and Requalification
Qualification of existing systems
Leveraging past experience
What and how much to test – risk-based approach
2.30 PM – 3.15 PM – Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Handling changes made by vendors
3.15 PM – 4.00 PM: Type and extend of qualification for USP Instrument Categories
The approach and benefits of instrument categories
How to identify the correct category: A, B, C
Type and extent of qualification for each category
Required procedures and qualification deliverables
Responsibilities for instrument qualification
4:00 PM – 4:15 PM – Break
4.15 PM – 5.00 PM – Requirements and approaches for GMP Computer Systems
21 CFR Part 211, Part 11, PIC/S, EU Annex 11
Most critical inspection findings
Which systems need to be validated
GAMP 5: A Risk based Approach to Laboratory Computerized Systems
Examples for risk assessment of computer systems
Validation of Laboratory Computer systems
Day 02 (10:00 AM – 5:00 PM EDT)
10.00 AM – 10.15 AM – Questions and answers from Day 1
10.15 AM – 11.00 AM – Validation and Use of Excel in the QC Laboratory
Designing spreadsheets for compliance
Validation approach for spreadsheets – single and multiple-use spreadsheets
When, what and how much to test?
GAMP 5 recommendations
How to ensure spreadsheet data integrity
11:00 AM – 11:15 AM – Break
11.15 AM – 12.15 PM – Configuration management and change control
The IEEE standard for configuration management
The change control process for planned changes
What to test after changes
How to document changes
12.15 PM – 1.00 PM – Periodic revalidation of chromatography data systems
The approach and practice of periodic review
Using periodic review to reduce frequency of revalidation
Criteria for time-based revalidation
Incidents requiring revalidation
Validation tasks after installing security and other patches
1:00 PM – 1:45 PM – Lunch
1.45 PM – 2.30 PM – Handling raw data and other laboratory records
Definition of raw data: electronic vs. paper
Acquisition and recording of raw data
How to make accurate and complete copies of raw data
Archiving of raw data and ready retrieval
2.30 PM – 3.00 PM – Ensuring Integrity and Security of GMP data
Most frequent security and integrity issues
The importance of electronic audit trails
Review of electronic audit trails: who, what, when, and how
3:00 PM – 3:15 PM – Break
3:15 PM – 4.30 PM – Auditing Laboratory Computer Systems
Using FDA inspection practice
Importance of data governance policy and controls
Preparing inspection-ready documentation
Responding to typical inspectional/audit observations
4.30 PM – 5.00 PM – Wrap up – Final questions and answers
Royal Society of Chemistry
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 more information about this training visit https://www.researchandmarkets.com/r/81q441
Research and Markets
Laura Wood, Senior Manager
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
View original content:https://www.prnewswire.com/news-releases/2-day-virtual-analytical-instrument-qualification-and-system-validation-course-august-16-17-2022-301597668.html
SOURCE Research and Markets
Here are the markets that will be open on Columbus Day, also recognized as Indigenous Peoples' Day, on Monday, Oct. 10.
Everyone knows that you should buy low and sell high if you want to turn a profit in the markets. The trick is finding the bottom, to know when to buy. Jim Cramer, the well-known host of CNBC’s ‘Mad Money’ program, sees the market bottom hitting in the next couple of weeks, making the end of October the right time for investors to buy in. Referring to some recent predictions by market technician Larry Williams, Cramer says, “The bear market is more or less… toast and, even if the current rally s
PayPal is in trouble. "You are independently responsible for complying with all applicable laws in all of your actions related to your use of PayPal's services, regardless of the purpose of the use," the document, called "Acceptable Use of Policy," said.
The year 2022 has been a painful journey for semiconductor manufacturers. Following the example of AMD , Nvidia and Intel , which are the three main players in the sector, 2022 is a year to forget .Their valuations are in recession. Advanced Micro Devices (AMD) currently has a market value of $94.4 billion, which is a decrease of at least $83 billion compared to December 31, 2021.
Tesla stock is forming a bearish head-and-shoulders pattern. And with CEO Elon Musk likely selling more stock to fund his Twitter purchase, shares of the electric-vehicle giant might have further to fall.
A market rally attempt is reeling as the indexes plunged on Friday's jobs report. Tesla, AMD and On Semi sold off.
For the retail investor, the only certainty of our current market environment is uncertainty. Volatility is up, and the main indexes are showing deepening losses. As if that wasn't enough, at least one market bull is turning a bit more pessimistic. JPMorgan strategist Marko Kolanovic has been one of the more bullish voices on Wall Street in recent months, but current conditions have him pushing the timeline back. While he still believes that the S&P 500 can hit 4,800, or a 32% gain from current
If you buy one between now and the end of October, you’ll earn a composite interest rate of 9.62%.
(Bloomberg) — Sign up for the New Economy Daily newsletter, follow us @economics and subscribe to our podcast.Most Read from BloombergRussia Races to Reopen Crimea Bridge Damaged in Fiery BlastPutin Orders Sakhalin-1 Project Transferred to Russian EntityMinecraft Star Dream Meets His Screaming Fans for First TimeFacebook Is Warning 1 Million Users About Stolen Usernames, PasswordsWall Street Is Missing the Risk to Stocks If Inflation Is BeatenGlobal finance chiefs gather in Washington in the co
“The thing about Finland is that when you ask a straight question you usually get a straight answer,” remarked one fan of Ms Marin
AMD stock is hitting 52-week lows as it reports disappointing preliminary revenue results. Here's when to buy the chipmaker's shares.
The veteran telecom company is having a stellar year in many respects, but reason for concern has emerged.
Wall Street tends to give stock splits more weight than they should have. Annaly's reverse split, however, might be a genuine warning sign.
In this article, we discuss the 10 best EV battery stocks to buy in late 2022. If you want to see more stocks in this selection, check out the 5 Best EV Battery Stocks to Buy in Late 2022. The share of EV sales has taken up more than 5% of the total new automobile […]In Musk v. Twitter, a part of the business life of the richest man in the world is revealed. Private messages exchanged with his inner circle immerse us into his process when he conceives an idea. The messages were released by the Delaware Chancery Court as part of the proceedings between the two parties.
The warehouse club has always been a little different when it comes to its policies on credit cards.
What do Amazon, Microsoft, and Google parent Alphabet have in common? The company develops ready-made and customizable AI solutions for hundreds of companies across different industries, which can materially accelerate their adoption of advanced technology. Cloud-computing technology is key to businesses that operate online in any capacity, and the three leading providers of cloud services happen to be Amazon Web Services (AWS), Microsoft Azure, and Google Cloud.
The right answer likely hinges on whether or not the Federal Reserve follows through with plans to raise its benchmark interest rate to 4.5% or higher, as market-based indicators and the Fed’s latest batch of projections anticipate. Global markets are on edge about the possibility of an emerging-markets crisis resulting from higher interest rates and a U.S. dollar at a 20 year high, or a slump in the housing market due to rising mortgage rates, or the collapse of a financial institution due to the worst bond market chaos in a generation. Fears that the Fed could cause something in the global economy or financial system to “break” have inspired some to question whether the Fed can successfully whip inflation by hiking interest rates by the most aggressive pace in decades without causing collateral damage.
Most S&P 500 investors consider Tesla stock to be the ultimate investment. But it turns out you could do better — much better.
Back in July, electric vehicle maker Polestar made a bold promise. The Gothenburg, Sweden-based company reported that it delivered 21,200 cars during the first six months of 2022, more than double the year-earlier figure.