Pharma 4.0: Cost-Effective Compliance with FDA’s 21 CFR Part 11
Myths Busted: Rethink FDA Compliance & Understanding What the FDA Really Wants!
Instructor :
Carolyn Troiano
Webinar ID:
10299
Date: DEC 18, 2024 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- Introduction To Pharma 4.0™: Overview Of 12 Theses.
- Pharma 4.0™ Operating Model Integrates Tech And Compliance.
- Breaking Silos: Enhancing Collaboration Across Sectors.
- Enabling Next-Gen Products With Pharma 4.0™.
- Investment Strategies For Pharma 4.0™ Innovation.
- Foundations: PQS And Controlled …
- Introduction To Pharma 4.0™: Overview Of 12 Theses.
- Pharma 4.0™ Operating Model Integrates Tech And Compliance.
- Breaking Silos: Enhancing Collaboration Across Sectors.
- Enabling Next-Gen Products With Pharma 4.0™.
- Investment Strategies For Pharma 4.0™ Innovation.
- Foundations: PQS And Controlled Processes Role.
- More Than IT: Embracing Organizational Change.
- Navigating Maturity With Pharma 4.0™ Model.
- Competitive Edge Through Mitigating Business Risks
Course Description
The FDA’s intensified scrutiny on data integrity and computer system validation underscores the critical need for compliance across all systems in regulated industries.
This scrutiny spans systems involved in the creation, management, and reporting of data—ranging from structured databases to unstructured documents and multimedia files. Ensuring the integrity of this data throughout its lifecycle is paramount for meeting FDA regulations.
In response to evolving technological landscapes, the FDA is spearheading a modernization initiative. This effort aims to refine their technological and procedural frameworks to enhance collaboration with the industry.
By adopting advanced technologies and forging strategic partnerships, the FDA seeks to not only ensure that regulated products adhere to compliance standards but also facilitate their expedited arrival on the market.
These advancements promise enhanced public health outcomes through safer, more effective products.
Pharma 4.0 emerges as a pivotal operating model in this context, integrating health regulation best practices to navigate the modern regulatory environment.
This course will delve into the cutting-edge strategies and best practices necessary for modernizing FDA-regulated computer systems.
From cloud computing to automated testing and mobile technologies, we’ll examine the components set to transform industry practices.
Participants will gain insights into:
- Evaluating current processes for compliance and modernization.
- Leveraging cloud computing, automated testing, and mobile devices to enhance GxP activities.
- Implementing industry best practices for data integrity and risk assessment.
Join us to equip yourself with the knowledge to streamline your compliance processes, ensuring your systems are not only FDA-compliant but also poised to leverage the latest technological advancements.
Empower your GxP work with Pharma 4.0 strategies—register now for a forward-thinking approach to compliance and data integrity.
Join Now!
The FDA’s intensified scrutiny on data integrity and computer system validation underscores the critical need for compliance across all systems in regulated industries.
This scrutiny spans systems involved in the creation, management, and reporting of data—ranging from structured databases to unstructured documents and multimedia files. Ensuring the integrity of this data throughout its lifecycle is paramount for meeting FDA regulations.
In response to evolving technological landscapes, the FDA is spearheading a modernization initiative. This effort aims to refine their technological and procedural frameworks to enhance collaboration with the industry.
By adopting advanced technologies and forging strategic partnerships, the FDA seeks to not only ensure that regulated products adhere to compliance standards but also facilitate their expedited arrival on the market.
These advancements promise enhanced public health outcomes through safer, more effective products.
Pharma 4.0 emerges as a pivotal operating model in this context, integrating health regulation best practices to navigate the modern regulatory environment.
This course will delve into the cutting-edge strategies and best practices necessary for modernizing FDA-regulated computer systems.
From cloud computing to automated testing and mobile technologies, we’ll examine the components set to transform industry practices.
Participants will gain insights into:
- Evaluating current processes for compliance and modernization.
- Leveraging cloud computing, automated testing, and mobile devices to enhance GxP activities.
- Implementing industry best practices for data integrity and risk assessment.
Join us to equip yourself with the knowledge to streamline your compliance processes, ensuring your systems are not only FDA-compliant but also poised to leverage the latest technological advancements.
Empower your GxP work with Pharma 4.0 strategies—register now for a forward-thinking approach to compliance and data integrity.
Join Now!
Why you should attend
Unlock the potential of efficient computer system validation within FDA-regulated environments through this enlightening session.
Move beyond the traditional, document-heavy processes that have dominated the industry for years, which are not only labor-intensive but also fraught with misconceptions about FDA expectations.
In this session, you’ll gain insights into:
- Decoding FDA Guidance: Clarifying what the FDA really expects from industry stakeholders, dispelling myths, and highlighting the essence of compliance documents.
- Innovative Validation Approaches: Exploring modern methodologies and technologies that streamline validation processes without compromising on quality or compliance.
- Comprehensive System Coverage: Whether it’s on-premise, cloud-based, or SaaS solutions, learn the nuances of validating various system types efficiently.
- Leveraging Vendor Documentation: Understand how to effectively use vendor documentation to reduce redundancy and align with your organizational standards, without solely relying on it as proof of compliance.
- Maintaining Validated States: Discover the practices and activities essential for keeping systems compliant over time.
Attendees will learn best practices that not only reduce time and cost but also ensure the delivery of systems in a validated state. This session is a must for those looking to modernize their validation processes, leverage new technologies, and maintain ongoing compliance with confidence.
Elevate your approach to system validation—join us to transform how you achieve and maintain compliance in a rapidly evolving regulatory landscape.
Enroll Now!
Unlock the potential of efficient computer system validation within FDA-regulated environments through this enlightening session.
Move beyond the traditional, document-heavy processes that have dominated the industry for years, which are not only labor-intensive but also fraught with misconceptions about FDA expectations.
In this session, you’ll gain insights into:
- Decoding FDA Guidance: Clarifying what the FDA really expects from industry stakeholders, dispelling myths, and highlighting the essence of compliance documents.
- Innovative Validation Approaches: Exploring modern methodologies and technologies that streamline validation processes without compromising on quality or compliance.
- Comprehensive System Coverage: Whether it’s on-premise, cloud-based, or SaaS solutions, learn the nuances of validating various system types efficiently.
- Leveraging Vendor Documentation: Understand how to effectively use vendor documentation to reduce redundancy and align with your organizational standards, without solely relying on it as proof of compliance.
- Maintaining Validated States: Discover the practices and activities essential for keeping systems compliant over time.
Attendees will learn best practices that not only reduce time and cost but also ensure the delivery of systems in a validated state. This session is a must for those looking to modernize their validation processes, leverage new technologies, and maintain ongoing compliance with confidence.
Elevate your approach to system validation—join us to transform how you achieve and maintain compliance in a rapidly evolving regulatory landscape.
Enroll Now!
Course Agenda
- Introduction to Pharma 4.0™: Overview of the “12 Theses” driving Pharma 4.0™ innovation.
- Pharma 4.0™ Operating Model: How it extends Industry 4.0 to medicinal products, integrating technology with regulatory compliance.
- Breaking Silos with Pharma 4.0™: Enhancing collaboration across industry, regulators, and stakeholders.
- Pharma 4.0™ for New and Established Products: Enabling next-generation products and creating new business cases.
- Investment in Pharma 4.0™: Innovative strategies for business case and investment calculations.
- Foundations of Pharma 4.0™: The role of a Pharmaceutical Quality System (PQS) and controlled processes.
- Pharma 4.0™: More Than IT: Embracing organizational, cultural, and resource aspects.
- Navigating Pharma 4.0™ Maturity: Aligning your organization with the Pharma 4.0™ maturity model.
- Pharma 4.0™ as a Competitive Edge: Understanding its value in mitigating business risks and seizing market advantage.
- Adapting Business Models: Leveraging Pharma 4.0™ for niche and personalized medicine.
- Q&A Session: Clarify doubts and discuss implementation strategies
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
- Introduction to Pharma 4.0™: Overview of the “12 Theses” driving Pharma 4.0™ innovation.
- Pharma 4.0™ Operating Model: How it extends Industry 4.0 to medicinal products, integrating technology with regulatory compliance.
- Breaking Silos with Pharma 4.0™: Enhancing collaboration across industry, regulators, and stakeholders.
- Pharma 4.0™ for New and Established Products: Enabling next-generation products and creating new business cases.
- Investment in Pharma 4.0™: Innovative strategies for business case and investment calculations.
- Foundations of Pharma 4.0™: The role of a Pharmaceutical Quality System (PQS) and controlled processes.
- Pharma 4.0™: More Than IT: Embracing organizational, cultural, and resource aspects.
- Navigating Pharma 4.0™ Maturity: Aligning your organization with the Pharma 4.0™ maturity model.
- Pharma 4.0™ as a Competitive Edge: Understanding its value in mitigating business risks and seizing market advantage.
- Adapting Business Models: Leveraging Pharma 4.0™ for niche and personalized medicine.
- Q&A Session: Clarify doubts and discuss implementation strategies
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Maximize the Learning Experience in A Group Setting!
- Information Technology (IT) Analysts
- IT Developers, IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
Maximize the Learning Experience in A Group Setting!
- Information Technology (IT) Analysts
- IT Developers, IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
Instructor Profile
Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
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.
