Description

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco and related product industries.  Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

We’ll discuss the Tobacco Control Act (2009) and the Deeming Rule (2016). We’ll also cover the new draft requirements for the Premarket Tobacco Application (PMTA) based on the Tobacco Product Manufacturing Practices (TPMPs), the draft of which was issued by the FDA in early 2023.

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from the FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

We will cover GAMP®5, 2^nd Edition, and how it aligns with CSA, providing a set of industry best practices based on critical thinking and following a risk-based approach. We will discuss non-linear forms of software development, testing, and release, such as the agile methodology.

You will also learn about pending and potential regulations and where the tobacco and related product industries are heading in terms of compliance requirements.

Areas Covered:-

• Tobacco Legislation (FDA)
• GxP Predicate Rules
• Tobacco Control Act of 2009
• Deeming Rule of 2016
• Proposed TPMPs (2023 Draft)
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC)
• Computer Software Assurance (CSA)
• Waterfall (linear) vs. Agile (non-linear) methodology for software development, testing and release
• Critical Thinking
• A risk-based approach to validation
• GAMP^®5, 2^nd Edition approach to system categorization and validation
• Implementation and validation of systems in compliance with FDA
• Roles, responsibilities, and training
• Documentation required for FDA compliance
• Maintaining a system in a validated state
• Electronic Records and Electronic Signatures (ER/ES) compliance (21 CFR Part 11)
• Data Integrity (ALCOA+ Principles)
• The ratio of system cost to compliance with FDA
• SOPs required for supporting a validated system
• FDA Trends in Compliance and Enforcement
• Industry Best Practices
• Q&A.

Background:-

FDA The Tobacco Control Act went into effect by FDA on June 22, 2009.   Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others.  The rule went into effect on August 8, 2016.

This action is a milestone in consumer protection – going forward, the FDA will be able to:

• Review new tobacco products not yet on the market
• Help prevent misleading claims by tobacco product manufacturers
• Evaluate the ingredients of tobacco products and how they are made
• Communicate the potential risks of tobacco products

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco-related industries.  Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

Why You Should Attend:-

You should attend if you work for a tobacco or tobacco-related product company in the manufacturing, quality, marketing, or distribution areas.  You should also attend if you are a retailer or own a vapor shop.

In particular, if you are responsible for systems and data (structured and unstructured) supporting FDA-regulated operations, you will benefit by understanding how to meet compliance through the validation and maintenance of a system in a validated state. You will also learn about electronic records and electronic signature compliance requirements, and the importance of maintaining data integrity.

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco and related product industries.  Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

Who Should Attend:-

• Information Technology (IT) Analysts
• IT Solution Architects, Developers & Testers
• IT Support Staff
• IT Cybersecurity Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Quality Control Personnel
• Quality Audit Personnel
• Supply Chain Specialists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by the FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements.