4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach, as well as how to incorporate it into the overall computer system validation program for individual systems that have this capability. In the late 1990s, the FDA enacted the 21 CFR Part 11 Guidance. Successful implementation across the pharmaceutical and other regulated industries resulted in mixed responses. There are explicit restrictions that arise when using ER/ES capability; this would include the elimination of print capability. This is done to prevent users from making decisions based on a paper records as opposed to the electronic records. Specific identification of users is mandatory to ensure the person signing the record is the same person whose credentials are being entered and verified by the system. Rules for changing passwords must be rigorously adhered to and the passwords must be kept secure. It’s crucial that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. There should be appropriate and clear segregation of duties i.e., the person recording the result is not the same as either the person reviewing or the person giving the final approval. 

Why You Should Attend:

Get a detailed understanding of the FDA regulations that are application to the FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems. This will help ensure you develop an appropriate validation strategy and achieve the meticulousness required to prove that a system does what it purports to do. We will also be able to ensure that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. ER/ES capability can vary, however, the approach should be based on the specific case and the risk of failing to meet the guidance associated with it. 

Seminar Agenda:

Session 1:

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable”Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))

Session 2:

• Validation Strategy
• System Risk Assessment
• GAMP 5 “V”Model
• 21 CFR Part 11
• Electronic Records/Electronic Signatures (ER/ES)
• Security, Access, Change Control and Audit Trail

Session 3:

• Validation Documentation
• 7 Most Common Problems with Validation
• FDA Audit Preparation
• Policies and Procedures
• Training and Organizational Change Management
• Industry Best Practices and Common Pitfalls

Who Should Attend:

• Information Technology Analysts
• Information Technology Managers
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors Engaged in Internal Inspection

Course Director: CAROLYN TROIANO ‎

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.