Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

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 know 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 in the seminar:

• 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

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.