NetZealous Successfully Completes Two-Day Seminar on the Topic, "Validation and Part 11 Compliance of Computer Systems and Data" by Dr. Ludwig Huber
It is essential for laboratories to qualify and validate analytical and other computer systems equipment to ensure that these are suitable for the intended use to which they are being put. The reason for which electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements is that they must ensure that the data contained in them are authentic, secure and available.
Fremont, CA, April 29, 2016 (Newswire.com) - Dr. Ludwig Huber, who is the Chief Advisor - Global FDA compliance at Labcompliance, was the Director of an extremely well received two-day, in person, live seminar that was organized by NetZealous, a leading provider of regulatory compliance trainings for a wide range of regulated industries, in Mumbai on April 28 and 29. This seminar was on the topic, “Validation and Part 11 Compliance of Computer Systems and Data”.
It is essential for laboratories to qualify and validate analytical and other computer systems equipment to ensure that these are suitable for the intended use to which they are being put. The reason for which electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements is that they must ensure that the data contained in them are authentic, secure and available.
How do laboratories ensure this? Only a firm and through grasp of both the letter and spirit of Part 11 and Annex 11 requirements will help them do this. Lack of understanding or implementation of these aspects is the direct reason for which so many laboratories get Warning Letters issued.
More details about the seminar can be had from: http://www.globalcompliancepanel.in/control/validation-part-11-compliance
Dr. Huber offered complete insight into the regulatory background needed for the participants and guided them through the complete equipment qualification, calibration and computer system validation processes from planning till reporting, which will help them steer clear of these hurdles.
Recent EU and FDA inspection documents clearly show that all aspects relating to qualifying and validating, as well as electronic laboratory records are taken very seriously by FDA inspectors. This was the background against which this two-day seminar was set.
A standout feature of this seminar was the high number of interactive exercises that was sprinkled, which engaged the participants for almost fifty percent of the duration of the seminar into the presentations.
The Director facilitated role play by creating small groups of participants to work on case studies and prepare the answers using prepared fill-in templates. He also offered guidance on how to access and download a large variety of tools such as SOPs, validation examples and checklists on a dedicated website. Guidance and provision of these readily usable and easily implementable tools went a long way in making the seminar all the more fun-filled and practical.
Very importantly, Dr. Huber also provided many additional bonus materials with which to make implementation easier and faster. Apart from templates and examples which facilitate development of inspection-ready documentation; Dr. Huber also offered these to participants:
o 70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
o 10 SOPs related to validation and qualification of equipment and computer systems, change-control, risk assessment, maintenance, security and integrity of electronic records
o Full Set of Qualification examples for an HPLC system
o Full set of Validation examples of a C
o Chromatographic Data System and a Document Management System
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About the Director:
Dr. Ludwig Huber is Chief Advisor - Global FDA compliance at Labcompliance, a global on-line resource for validation and compliance issues for laboratories.
He has been Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences, and served as team member of PDA's task force’s “21 CFR Part 11”, of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
In addition to being awarded “Presenter of the Year of the Institute for Validation and Technology”, Dr. Huber has authored the books, Validation and Qualification in Analytical Laboratories, and Validation of Computerized Analytical and Networked Systems.
About NetZealous:
NetZealous, a Fremont, CA-registered organization, dba GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
Satisha Naraharimurthy, CEO of NetZealous, said at the conclusion of the two days of this seminar that this learning was just what participating laboratories needed at a time when the number of Warning Letters that have been getting issued in the industry has been steadily going up. He hopes that the learning Dr. Huber imparted will help this seminar’s participants address this critical issue.
“I am glad that we organized this seminar at a time when laboratories needed a good level of guidance on core issues relating to equipment qualification, calibration and computer system validation processes. I am all the happier that we were able to offer them the kind of guidance that will help them steer clear of their nagging issues”, said Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous.
Where this seminar stood out is in the fact that it was not only filled with substance, what with the Director offering valuable tools and templates to supplement learning and ease implementation, but was also very lively and engaging, said Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.
Contact information:
Call: 1-800-447-9407;
Visit: http://www.netzealous.com/
Source: http://www.netzealous.com/