FDA Electronic Recordkeeping & Signatures - 21 CFR Part 11
(On-site or Virtual Private Group/Company Training)
Location: On-site or Virtual
Who: Your entire company, department, project team, you select
Overview:
Get the latest information on 21 CFR Part 11. A lot has been said and conjuctured about Part 11. Get the real story and what you need to be doing about it. FDA has published the “Scope and Application” guidance as related to 21 CFR Part 11 in addition to the withdrawal of multiple Part 11 guidance and compliance policy. It is important for companies to keep in mind that 21 CFR Part 11 is still in effect. FDA promulgated Part 11 to provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. This seminar provides a complete overview of Part 11 and addresses the latest legal and regulatory compliance concerns while presenting case studies by FDA regulated manufacturers to highlight current strategies for how to address Part 11 in light of this latest FDA guidance. This course is applicable to executives, Information Technology Professionals, Legal, and RA/QA Managers responsible for implementing and maintaining regulatory compliance aspects of electronic recordkeeping systems. It is also beneficial for software development, software validation, manufacturing, and quality systems personnel. Audit Checklists will be presented that can be used to demonstrate effective compliance with Part 11 per FDA latest guidance.
What you will learn:
- What should you be doing about Part 11 today.
- 21 CFR Part 11 is still a regulation and is still in effect and enforceable!
- Understand the impact of FDA’s latest guidance.
- Understand the Part 11 implications of the Sarbanes-Oxley Act and HIPAA.
- Planning New Purchases? Still have a Legacy Systems?...learn what to do.
- Using “enforcement discretion” and the Predicate Rule aspects of validation, archiving, copying, audit trails, and the "grandfathering" of legacy systems.
- Latest strategic compliance aspects related to 21 CFR Part 11.
- Requirements for Open versus Closed Systems.
- What is expected for Computer System Validation & Vendor qualification.
- Using a “risk based approach” for efficient implementations and compliance.
- Legal aspects of current FDA enforcement. Don't be surprised!
Benefits of Attending:
- Capitalize on the opportunity to develop and implement strategic plans for long term FDA compliance with Part 11.
- Provide information necessary to assess and implement FDA compliant electronic recordkeeping systems under the latest FDA guidance.
- Ensure that your company is certified for using electronic signatures.
- Learn efficient methods for compliance, implementation and validation.
- Enable use of latest technologies for efficient company operations.
- Learn methods to determine practical Regulatory Risk versus Cost Benefits.
Abbreviated Outline:
- A. Impact of latest Scope & Applicable FDA guidance-What to do now?
- B. Legal & Regulatory aspects of Part 11 in current environment
- C. Overview of 21 CFR Part 11
- D. Implications of the Sarbanes-Oxley Act and HIPAA
- E. Procedures & Controls for Closed Systems and/or Open Systems
- F. Computer System Validation issues
- G. Protection of Records, Authority Checks & Audit Trails
- H. Operational System Checks & Device Checks
- I. Electronic Signature Requirements, Components & Controls
- J. Case Studies from Industry for Part 11 strategic planning
- K. Q&A for Frequently Asked Questions
- L. Audit Checklists
Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.
Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.
