21CFR Part 11 - Predicate Rules Compliance

Many companies lack a good understanding of what FDA requires in complying with predicate rules and 21 CFR part 11 at the same time. This webinar will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.

Why should you Attend

• Part 11 compliance has always been murky.
• FDA has issued guidance on part 11 compliance.
• FDA has issued guidance on what to do about the predicate rules.
• Part 11 is being re-written, and companies need advice on how to comply with the current and future regulation.

Areas Covered in the seminar:

• Review of FDA 21 CFR Part 11 regulation.
• Detailed discussion of FDA predicate rules regulation.
• Relationship between predicate rules and 21 CFR Part 11.
• Common confusion points.
• Practical guidelines on compliance.
• What's in it for you to comply.
• Predicate rules examples.
• Examples of predicate rule compliance failures.

Who will benefit:

This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:

• Quality, manufacturing and other personnel who are responsible for compliance to predicate rules and 21 CFR Part 11
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

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.