FDA Trends for Computer System Validation (CSV) Compliance and Enforcement Seminar

Global Compliance Seminars

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Course Description

Course "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This seminar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

As a "GxP" system following Good Manufacturing, Laboratory and Clinical Practices; the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.

This seminar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Why you should attend:

FDA requires all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered in the Session:
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- "GxP" - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data Archival to ensure security, integrity and compliance
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Policies and Procedures
- Critical Training
- Recent FDA findings for companies in regulated industries
- Recent trends in technology that need to be addressed in the CSV approach
- Q&A
Who Will Benefit:
Personnel in the following roles will benefit:
- Information Technology Analysts
- 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 the internal inspection of labeling records and practices

Agenda:

Day 1 Schedule

Lecture 1 (90 Mins):

Overview and Background: Computer System Validation (CSV)

Lecture 2 (90 Mins):

System Development Life Cycle (SDLC) Methodology

Lecture 3 (90 Mins):

GAMP 5 and Software Categorization

Lecture 4 (90 Mins):

System Risk Assessment and Management

Day 2 Schedule

Lecture 1 (90 Mins):

21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)

Lecture 2 (90 Mins):

Security and Access
Testing and Validation

Lecture 3 (90 Mins):

Policies and Procedures
Training and Expertise
Documentation

Lecture 4 (90 Mins):

Recent FDA findings for companies in regulated industries
Recent trends in technology that need to be addressed in the CSV approach
Q&A / Wrap-Up

Speaker:

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in Computer System Validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA's guidance on electronic records and electronic signatures (ER/ES).

Credits Available

More Seminar Information

Global Compliance Panel
Summary	This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.
Delivery Method	Seminar
Who Should Attend