The chief objective of this seminar was to inculcate in the participants both the letter and spirit of Part 11 and Annex 11 requirements.
Online PR News – 26-April-2016 – Fremont – Fremont, CA, Apr. 26, 2016: NetZealous, a leading provider of regulatory compliance trainings for a wide range of regulated industries, successfully completed a two-day seminar in Singapore on April 25 and 26. The Director of this learning session was Dr. Ludwig Huber, who is the Chief Advisor -
Global FDA compliance at Labcompliance, and the topic, “Validation and Part 11 Compliance of Computer Systems and Data”.If laboratories have to demonstrate that their analytical and other computer systems equipment are suitable for the intended use to which they are being put; it is necessary for them to qualify and validate the same. The assurance that the data contained in electronic records are authentic, secure and available is the reason for which electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements.
The chief objective of this seminar was to inculcate in the participants both the letter and spirit of Part 11 and Annex 11 requirements. Since this understanding in its entirety is necessary to ensure document integrity and other requirements for electronic records and signatures; this seminar imparted it.
More details about the seminar can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900336SEMINAR?validation-part-11-compliance-Singapore
Recent EU and FDA inspection documents amply demonstrate that FDA inspectors take all aspects pertaining to qualifying and validating, apart from electronic laboratory records very seriously. The fact that the industry has a big problem in either understanding or implementing the regulations is shown by the huge number of Warning Letters that they get issued by the FDA.This current situation of laboratories vis-à-vis these issues they have with the FDA provided the background to this two-day seminar.
This is why offering insight into the regulatory background needed for the participants and guide them through the complete equipment qualification, calibration and computer system validation processes from planning till reporting was the main aim of this valuable seminar.
In addition to providing a thorough and full understanding of the regulations and guidelines for equipment and records; the Director, Dr. Huber also provided templates and examples to develop inspection ready documentation. Another important focus of this seminar was the high number of interactive exercises that was interspersed into the presentations. Nearly half the seminar time was taken up in practical sessions.
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.
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.
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, biological, drugs, food and biotechnology.
CEO of NetZealous, Satisha Naraharimurthy, has expressed his happiness and satisfaction that this seminar was held at a time when laboratories are seen to be struggling with their core issues relating to equipment qualification, calibration and computer system validation processes. He is satisfied that his organization served an important learning need for such professionals.
An understanding of what laboratory professionals need to do in order to meet regulatory requirements was what this seminar intended to impart, and it has done its job rather well, felt Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous.
The learning gained at this two-day seminar, which was packed with both substance and articulation, will go a long way in helping laboratory personnel at various levels understand ways by which to sort out the issues they have in relation to equipment qualification, calibration and computer system validation processes, believes Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.