Mumbai, 20th July 2017: CPhI Conferences, a division of UBM India which hosts a number of successful pharmaceutical conferences, is pleased to announce the 4th edition of ‘Computer System Validation’ Workshop slated for 9th and 10th November 2017 at the Meluha, The Fern An Ecotel Hotel, Mumbai.
In recent years, computerized systems have become a vital part of the pharmaceutical and medical device industries. Global regulatory authorities are getting stringent with companies to adopt a risk-based approach to validate computer systems and compliance with the authority guidelines. Unclear Lack of clear understanding of validating computer systems can adversely affect the drug quality and patient safety.
Validation of computer systems has evolved over the last decade and now it is considered as an integral part of GxP requirements. While the methodology has developed and advanced with the latest version of GAMP (Good Automated Manufacturing Practice) guidelines, the complexity of software technology still leaves a gap between the regulatory expectations and the awareness of the guidelines. This can result into increased scrutiny by FDA which may lead to warning letters received by pharmaceutical companies.
To ensure that companies successfully pass FDA inspections and to also make sure that system and its applications fulfil its intended purpose, CPhI Conferences through this workshop will offer professionals from the pharmaceutical industry an understanding of regulatory requirements and risk based approach under GAMP5 guidelines, how to deal with data integrity related issues with the support of good documentation practices, knowledge of overall challenges that occur during validation and strategies to overcome those challenges.
This year, the workshop will feature Mr. Sam Brooks, an internationally recognized expert in the area of computer system validation for pharmaceuticals and process equipments. His role has developed through real-time software development, engineering maintenance and governance of IT teams. Mr. Sam Brooks has worked with both large and small pharmaceuticals companies on various aspects of computer system validation. He has led and delivered integrated strategies for achieving IT compliance with corporate computer systems validation and information security at Novartis as OTC global head IT compliance.
Key topics of the workshop include, ‘regulatory requirements and recommendations under 21CFR part 11’, ‘strategies for good documentation practices’, ‘recent 483s issued on CSV and data integrity’, ‘validating PLC machines’, ‘cloud and mobile application validation’, and ‘risk assessment for software and systems’ amongst others.
About UBM India:
UBM India is India’s leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences & seminars. UBM India hosts over 25 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia.
For further details, please visit www.ubmindia.in.
About UBM plc:
UBM plc is the largest pure-play B2B Events organiser in the world. In an increasingly digital world, the value of connecting on a meaningful, human level has never been more important. At UBM, our deep knowledge and passion for the industry sectors we serve allow us to create valuable experiences where people can succeed. At our events people build relationships, close deals and grow their businesses. Our 3,750+ people, based in more than 20 countries, serve more than 50 different sectors – from fashion to pharmaceutical ingredients. These global networks, skilled, passionate people and market-leading events provide exciting opportunities for business people to achieve their ambitions.
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