Pack of THREE: 3-Hour Online Seminar on FDA 21 CFR Part 11 By 3 FDA Expert

Product Id: 30996PACK

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Instructor : Dr. Ludwig Huber
Product Id : 30996PACK

Overview: FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

The webinar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

Areas Covered in the Session:
  • FDA's current inspection and enforcement practices
  • FDA's new interpretation: learning from FDA inspection reports
  • Strategy for cost-effective implementation of Part 11: A six step plan
  • Justification and documentation for the FDA and your management
  • Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management
  • Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues
  • How to prepare your company for Part 11 Inspections

For Easy Implementation, Attendees Will Receive:
  • Checklist: Part 11 compliance
  • Case Studies: How to avoid Part 11 related 483's and Warning Letters
  • SOP: Electronic Audit trail: Specifications, Implementation, Validation

Who Will Benefit:
  • QC Managers
  • QA Managers and Personnel
  • IT Administrators
  • Analysts
  • Regulatory Affairs
  • Training Departments
  • Documentation Department
  • Consultants


Instructor : Angela Bazigos
Product Id : 30996PACK

Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Why should you attend: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Areas Covered in the Session:
  • Requirements for Excel Spreadsheets
  • FDA Part 11 Validation Guidance
  • Compliance Problems with Spreadsheets
  • Design Specifications for 21 CFR 11 compliance
  • How does the FDA Design and Use spreadsheets
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Small business owners
  • Internal and external auditors
  • Management Reps
  • FDA inspectors
  • Consultants


Instructor : Edwin Waldbusser
Product Id : 30996PACK

Overview: This webinar details the regulation and how it applies to computerized systems.

Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Areas Covered in the Session:
  • Which data and systems are subject to Part 11
  • What Part 11 means to you, not just what it says in the regulation
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Who Will Benefit:
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals


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NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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