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    Risk-based Computer System Validation; Reduce Costs and Avoid 483

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    Website | Edit Freely


    Deadline: April 12, 2020 | Date: April 22, 2020-April 23, 2020

    Venue/Country: Scottsdale, AZ, U.S.A

    Updated: 2020-03-25 21:05:45 (GMT+9)

    Call For Papers - CFP

    It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.

    The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

    Understand the specific requirements associated with local and SaaS/cloud hosting solutions.

    It details the requirements for HIPAA Protect Health Information (PHI)

    Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

    The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.

    Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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