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About the Speaker Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com). For More Info Click Here ">Why is software validation necessary? In today’s environment in which everything seems to be going online, electronic signatures are here to stay. They will become the accepted norm in the future, in which it will not be necessary to ink a document. This change is irreversible, but how do organizations ensure that computerized systems carry genuine signatures? The answer is software validation. The 21 CFR, Part 11 Guidelines for this validation are set out in 21 CFR Part 11. The aim of this seminar is to help participants understand how regulations set out in this Part are relevant to them and how they impact these organizations. The seminar is essentially about 21 CFR Part 11, software validation, and computer systems validation. It provides insight into the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. Being unshakably strong at 21 CFR Part 11, software validation, and computer system validation is crucial for an organization. Unless these components are strongly and firmly in place; the organization stands at risk of inviting a 483 and Warning Letters from the FDA. This seminar will help participants understand how to fortify these elements of validation. What else will this seminar impart? The speaker, David Nettleton, who has several years of experience at computer systems validation, will take participants through what is needed to comply with 21 CFR Part 11. It is important for companies to read between the lines of these regulations, in which there are several “hidden meanings”, interpretations and explanations.When companies are familiar with all these intricacies, it helps them avoid Warning Letters and 483s. This seminar will do just that. Benefits There is a whole wealth of benefits to be experienced by attending this two-day seminar. Participants can ensure data integrity, security, and protect intellectual property.They can have a better grasp of the current computer system industry standards for security, data transfer, and audit trails, which are among other areas covered in this seminar. Most importantly… When more enhanced and effective software validation systems are put in place, an organization can save hugely on resources and time. At this seminar, the expert will come up with tips using which organizations can save a whopping two-thirds of their costs on validation by implementing his suggestions. Among other areas, the speaker detail all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation. A grasp of advanced concepts such as how to "right size" change control methods that allows quick and safe system revalidation and reducing testing time, and preparing documents that avoid 483s and warning are the other benefits of this seminar. o It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation o The course is highly interactive, using real life examples and proven techniques. o Participants will learn how to use electronic records and electronic signatures to maximize productivity o This course will teach participants ways by which to prepare for an audit as is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors o The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation o Participants will be able to learn how to reduce testing time, and how to prepare documents that avoid 483s and warning letters. About the Speaker Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com). For More Info Click Here
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