Software Validation and 21 CFR Part 11 Remediation Planning: FDA Inspection Strategies

Duration: 90 Minutes
All computer systems which store data which is used to make quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any laboratory results used to determine quality, safety, strength, efficacy, or purity. In clinical environments, this includes all data to be reported as part of the clinical trial used to determine quality, safety, or efficacy. In manufacturing environments, this includes all decisions related to product release and product quality.
21 CFR part 11 Validation
Instructor: Alfonso Fuller
Product ID: 504251
Objectives of the Presentation
  • FDA software validation expectations explained
  • 21 CFR Part 11 Electronic Records - FDA regulations explained
  • 21 CFR part 11 Electronic Signatures - when do regulations apply
  • Planning to remediate existing non-compliant systems
  • FDA inspection strategies - software validation and Part 11 compliance
  • Preparing for FDA inspection
  • Understanding how to respond to FDA observations
Why Should you Attend
Today's manufacturing and quality environments are highly automated and computerized. Manufacturers facing FDA pre-approval inspections (PAI) as well as those who will be re-inspected following inspectional observations (FDA-483), warning letters and other compliance issues can expect FDA to pay increasing attention to automated manufacturing systems and computerized quality systems. If you have outstanding issues known to your quality unit or to FDA, now is the time to initiate remediation efforts! This presentation provides concrete strategies for planning remediation projects.

Areas Covered
  • Review current FDA inspection of automated manufacturing systems
  • Review current FDA inspection of quality system software, such as complaints, CAPA, etc
  • How do I determine which systems require remediation?
  • What are the planning issues for a remediation project?
  • Special considerations for multi-site and global systems
  • Software validation concerns
  • 21 CFR part 11 (Electronic Records and Electronic Signatures) concerns
  • Remediation project planning guidelines
Who will Benefit
Companies that manufacture, sell, or distribute Pharmaceuticals, Medical Devices, Biologics will benefit from this webinar, as well as vendors and suppliers who support them. Personnel who will benefit include:
  • Management responsible for operational and quality systems ("system owners")
  • QA Directors, Managers and personnel
  • IT / IS Managers and personnel
  • Software Validation and Software Quality Managers + Personnel
  • Consultants charged with creating or evaluating part 11 programs
  • Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
  • Quality auditors responsible for auditing and evaluating part 11 compliance
Topic Background
Validation is the process of compiling written verification of all system functions and the performance of those functions to system specifications, as well as data integrity and system maintenance. That written documentation must be in alignment with the industry standards and regulatory laws that guide the FDA in their evaluation and enforcement of regulatory compliance. To successfully manage compliance, each regulated system must be proven to operate in accordance with its intended use and design, and all documentation supporting that evidence must culminate in FDA-acceptable documentation.
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Instructor Profile:
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers. He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.
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