Good Documentation Practices to Support FDA Computer System Validation

Course Description
Course Qualification
Presenter
FAQ

Course Description

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

In December 2018, FDA issued a guidance document on Data Integrity (DI), which has seen an alarming increase in DI issues during inspection of regulated firms. This upward trend continues and is of particular interest during FDA inspection.

In this CPE webinar, we will explore good Documentation Practices to Support FDA Computer System Validation.

Learning Objectives

To discuss the requirements for documenting efforts related to systems governed by FDA.
To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures.
To review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable.
To analyze how to prepare a procedure that will capture the best practices for FDA compliant documentation.
To discuss the importance of training as it relates to good documentation practices to ensure FDA compliance.

Recommended For

This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Documentation Practices to Support FDA Computer System Validation.

Who Should Attend?

Assistant Controllers
Business Owner
Certified Information Technology Professionals
CPA (Industry)
CPA - Mid Size Firm
CPA - Small Firm
CPA in Business
Entrepreneurial CPA
Information Reporting Officers
Young CPA

Course Qualification

Webinar Qualifies For

1.5 CPE Credit for Certified Information Systems Auditor (CISA)
1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 CPD Credit for Certified Information Technology Professionals (CITP)
1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
1.5 CE Credit for Certified Wealth Strategist (CWS)
1.5 General Credit for Accountant/Bookeeper
1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)

Additional details

Course Level :

Basic
Credits :

1.5
Instructional Method :

Group Internet Based
Pre-requisites :

None
Advance Preparation :

None

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Presenter

About Presenter

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

About Company

BrainStorm Central Consulting LLC

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.

"Our experience will lead you to us, your experience will keep you coming back..."

FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Faq

FAQs content

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