Best Practices in Preparation for an FDA Computer System Audit

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Course Description
Course Qualification
Presenter
FAQ

Course Description

Overview

FDA regulatory oversight and "GxPs"

2 mins
Regulatory influences

33 mins
Vendor audit and management

39 mins
CSV policies and procedures

60 mins
Incomplete or inadequate testing

70 mins

Course Description

As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the computer system must be validated following 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 CPE webinar will focus on the most important key areas, including data 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.

In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into production in a validated state and how each system is maintained in that validated state with the data integrity assured.

It’s important to have the right resources and understanding of the process before any inspection. Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.

This online CPE webinar on Information Technology will help you learn some tips based on real FDA inspections.

Learning Objectives

To discuss the regulatory influences that lead to FDA’s current thinking at any given time.
To analyze how to best prepare for an FDA inspection or audit of a GxP computer system.
To analyze best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs.
To explain the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver to be able to defend the decision to choose them.
To analyze the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle.
To inspect how to identify “GxP” Systems.
To discuss the Computer System Validation (CSV) approach based on FDA requirements.
To investigate the System Development Life Cycle (SDLC) approach to validation.
To analyze how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
To comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches.
To analyze how to maintain a system in a validated state through the system’s entire life cycle.
To discuss how to assure the integrity of data that supports GxP work.
To investigate the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.

Recommended For

This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Best Practices in Preparation for an FDA Computer System Audit.

Who Should Attend?

CEO
Certified Information Technology Professionals
Compliance Managers
Compliance Officers
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 General Credit for Accountant/Bookeeper
1.5 CPE Credit for Certified Information Systems Auditor (CISA)
1.5 CPD Credit of IT Governance and Strategy for Certified Information Technology Professionals (CITP)
1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
1.5 CE Credit for Certified Wealth Strategist (CWS)
1.5 CPE Credit for Certified Government Auditing Professional (CGAP)
1.5 CPE Credit of Information Technology for Certified Internal Auditors (CIA)
1.5 CPE Credit for Internal Audit Practitioner (IAP)
1.5 CPE Credit for Qualification in Internal Audit Leadership (QIAL)
1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
1.5 CRE Credit of Information Technology (inc. Excel) for Certified Corporate FP&A Professional (FPAC)

Additional details

Course Level :

Basic
Credits :

1.5
Instructional Method :

QAS Self Study
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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