21 CFR Part 11: Webinar on FDA Guidelines for Electronic Records and Electronic Signatures – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “21 CFR Part 11, FDA Guidelines for Electronic Records and Electronic Signatures” webinar was added to from ResearchAndMarkets.com offer.

This webinar is intended for individuals involved in planning, executing, and supporting computer system validation activities, working in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, tobacco pouches, cigars, etc.).

Applicable functions include research and development, manufacturing, quality control, distribution, clinical testing and management, sample labeling, adverse event management, and post-marketing surveillance.

This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidelines for computer systems subject to FDA regulations. This is essential for developing the appropriate validation strategy and achieving the rigor required to prove that a system does what it is supposed to do.

It also ensures that a system is maintained in a validated state throughout its life cycle, from design to retirement. ER/ES capability may vary, and the approach should be based on the specific case and the risk of not meeting the associated guidelines.

The FDA’s 21 CFR Part 11 was enacted in the late 1990s, and the success of its implementation in the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to an electronic record.

It also requires very specific user identification which ensures that the person signing the record is the same person whose credentials are entered and verified by the system. Rules for changing passwords must be strictly adhered to and passwords must be kept in a safe place.

It is also essential that the system specifies the exact meaning of the signature. The person may have performed the work, recorded the result, reviewed the result, or approved the result. A person can simply attest to the fact that they have reviewed the work and the signatures, and that there has been an appropriate segregation of duties (i.e. the person recording the outcome is not the same as the person reviewing or the person giving final approval).

A company should have specific policies and procedures in place that explicitly state responsibilities and provide guidance for the implementation and use of RE/ES capability. These should clarify 21 CFR Part 11 and provide insight into how the company interprets its responsibility to comply. As the FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.

New technologies will continue to emerge and change the way companies do business. While many of them aim to streamline operations, reducing time and resources, some unintentionally result in additional layers of monitoring that clutter a computer system validation program and require more time and resources, which makes the technology unattractive from a cost-benefit perspective.

Who will benefit from this webinar includes:

  • Information technology analysts

  • IT developers and testers

  • QC/QA managers and analysts

  • Analytical chemists

  • Compliance and Audit Managers

  • Laboratory managers

  • Automation analysts

  • Manufacturing specialists and managers

  • Supply chain specialists and managers

  • Regulatory Affairs Specialists

  • Regulatory Submission Specialists

  • Risk management professionals

  • Clinical data analysts

  • Clinical Data Managers

  • Clinical Trial Sponsors

  • Computer system validation specialists

  • GMP Training Specialists

  • Business Stakeholders/Subject Matter Experts

  • Business systems/application testers

  • Suppliers responsible for software development, testing and maintenance

  • Suppliers and consultants working in the life sciences industry who are involved in the implementation, validation and compliance of IT systems

Main topics covered:

  • Computer System Validation (CSV)

  • System Development Life Cycle (SDLC) Methodology

  • Good “Variable” Practices (GxP) (Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP))

  • Data Integrity (DI)

  • Validation strategy, planning and execution

  • System Risk Assessment

  • GAMP 5 “V” Model and Software Categorization

  • 21 CFR Part 11, FDA Guidance on Electronic Records/Electronic Signatures (ER/ES)

  • Security, access, change control and audit trail

  • Criteria required to ensure that data is created and maintained with integrity throughout its lifecycle

  • Policies and procedures to support CSV and DI assurance

  • Training and management of organizational change

  • Current FDA Compliance and Enforcement Trends

  • Industry best practices and common pitfalls

  • Questions and answers

For more information on this webinar, visit https://www.researchandmarkets.com/r/ci4f0o

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