Data Integrity and Management in the Pharmaceutical Industry. Understanding and Complying with GMP & FDA requirements.

Data Integrity and Management in the Pharmaceutical Industry. Understanding and Complying with GMP & FDA requirements.

04/17/2018, 11:30 AM - 12:15 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall

Language:
English

♦Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management systems provide a missing link in such circumstances, allowing secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes. Complying with the new more demanding requirements and bringing manufacturing processes and control to a new level is a challenge that cannot neglect full data integrity related standards compliance. The "Data Integrity in Pharma" presentation will teach those new to electronic data management basic terminology understanding and "must have" SOP creation. Advanced users will get a detailed interpretation of the primary standards, an overview of the modern available technology, and the best practices for secure and reliable data storage. The answers to frequently asked questions from our worldwide customer panel will also be provided. Learn more about: ♦ The "must know" standards to adopt for a controlled and certified production environment - (Data collection, transferring and storage according to 21 CFR part 11, GMP Annex 11, ISPE GAMP, MHRA) ♦ How to minimize the risk of non-conformances by understanding your process and cleanroom performance. - (Automated data trend analysis and understanding possible risks before they become a concern) ♦ The importance of cultivating an ethical approach to the data management - (Prevention of non-ethical behavior is an essential step to compliance) ♦ How to become and stay compliant, and prepare for future standard changes.

Contributors

  • Daniele Pandolfi

    Speaker

    Product Line Manager - Life Science

    Particle Measuring Systems

    Daniele Pandolfi Particle Measuring Systems - Life Science Division Global Product Line Manager, Aerosol dpandolfi@pmeasuring.com Daniele Pandolfi...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. • The “must know” standards to adopt for a controlled and certified production environment o (Data collection, transferring and storage according to 21 CFR part 11, GMP Annex 11, ISPE GAMP, MHRA) 2. • How to minimize the risk of non-conformances by understanding your process and cleanroom performance. o (Automated data trend analysis and understanding possible risks before they become a concern) 3. • The importance of cultivating an ethical approach to the data management o (Prevention of non-ethical behavior is an essential step to compliance) • How to become and stay compliant, and prepare for future standard changes.

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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