Next-Gen Compliance Mastery Pack: 3 Courses on AI/ML, Lean Management, and Clinical Data
Is Your Compliance Strategy Ready for FDA’s Newest Game-Changers?
Instructor :
Multiple Speakers
Webinar ID:
11927
Date: DEC 27, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT each day
Duration: 4.5 Hrs.
What you will learn
-
- Validate AI/ML Programs with Comprehensive Testing Protocols
- Define Success Criteria and Conduct AI/ML Validation Studies
- Compile Validation Tracking Matrix for Detailed Data Analysis
- Apply Lean Principles to Streamline FDA-Regulated Project Management
- Manage Project Design Inputs and Outputs Effectively
- Execute Design Verification and ….
-
- Validate AI/ML Programs with Comprehensive Testing Protocols
- Define Success Criteria and Conduct AI/ML Validation Studies
- Compile Validation Tracking Matrix for Detailed Data Analysis
- Apply Lean Principles to Streamline FDA-Regulated Project Management
- Manage Project Design Inputs and Outputs Effectively
- Execute Design Verification and Validation for Regulatory Compliance
- Conduct Gap Analysis to Identify Key Project Weaknesses
- Understand TMF’s Critical Role in Clinical Trial Compliance
- Organize and Maintain TMF Data for Regulatory Readiness
- Prepare TMF Records for Successful Regulatory Inspections
- Implement Industry Best Practices for Managing Clinical Data Integrity
Webinar Pack Description
Included Courses in the Advanced FDA Compliance and Management Pack:
-
- Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Duration: 1.5 Hrs. | Scheduled Date: Sep 25, 2024 | Time: 10:00 AM – 11:30 AM PT
-
- Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Clinical Data Management and Trial Master File Compliance Under FDA Standards
- Duration: 1.5 Hrs. | Scheduled Date: Sep 26, 2024 | Time: 10:00 AM – 11:30 AM PT
- Clinical Data Management and Trial Master File Compliance Under FDA Standards
-
- Lean Project Management for FDA-Regulated Environments: Principles and Applications
-
- Duration: 1.5 Hrs. | Scheduled Date: Sep 30, 2024 | Time: 10:00 AM – 11:30 AM PT
-
- Lean Project Management for FDA-Regulated Environments: Principles and Applications
Key Benefits of the Pack:
-
- Flexible Participation: You can nominate different participants for each course; gift them to various team members for broader learning.
- Extended Access: 12-month unlimited access to the recordings—6 months extra than the standard access period.
- Presentation Handouts: Receive a PDF copy of each course’s presentation for future reference.
- Completion Certificate: Request a soft copy of the certificate of completion for professional development.
- Interactive Q&A Sessions: Engage with the presenter through Q&A sessions to get your pressing questions answered via chat, email, or live.
Pack Description:
This 3-course pack equips you with advanced insights into AI/ML regulations, lean project management, and clinical data compliance—key areas reshaping FDA-regulated industries.
As businesses face increasing regulatory complexity, now is the time to enhance your compliance strategies, streamline project execution, and fortify clinical data practices. Designed for the modern compliance leader, this pack offers …
Included Courses in the Advanced FDA Compliance and Management Pack:
-
- Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Duration: 1.5 Hrs. | Scheduled Date: Sep 25, 2024 | Time: 10:00 AM – 11:30 AM PT
-
- Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Clinical Data Management and Trial Master File Compliance Under FDA Standards
- Duration: 1.5 Hrs. | Scheduled Date: Sep 26, 2024 | Time: 10:00 AM – 11:30 AM PT
- Clinical Data Management and Trial Master File Compliance Under FDA Standards
-
- Lean Project Management for FDA-Regulated Environments: Principles and Applications
-
- Duration: 1.5 Hrs. | Scheduled Date: Sep 30, 2024 | Time: 10:00 AM – 11:30 AM PT
-
- Lean Project Management for FDA-Regulated Environments: Principles and Applications
Key Benefits of the Pack:
-
- Flexible Participation: You can nominate different participants for each course; gift them to various team members for broader learning.
- Extended Access: 12-month unlimited access to the recordings—6 months extra than the standard access period.
- Presentation Handouts: Receive a PDF copy of each course’s presentation for future reference.
- Completion Certificate: Request a soft copy of the certificate of completion for professional development.
- Interactive Q&A Sessions: Engage with the presenter through Q&A sessions to get your pressing questions answered via chat, email, or live.
Pack Description:
This 3-course pack equips you with advanced insights into AI/ML regulations, lean project management, and clinical data compliance—key areas reshaping FDA-regulated industries.
As businesses face increasing regulatory complexity, now is the time to enhance your compliance strategies, streamline project execution, and fortify clinical data practices. Designed for the modern compliance leader, this pack offers the essential skills needed to stay competitive, mitigate risks, and navigate the latest FDA standards before year-end deadlines.
” Webinar 1: Navigating FDA Regulations for AI/ML in Clinical Settings (Sep 25, 2024)”
Description:
-
- Gain expert insights into FDA’s evolving regulations for AI/ML in clinical settings, a critical area as digital innovations surge.
- This course is essential for professionals adapting to AI-driven processes and ensuring compliance amidst new FDA requirements.
- Learn practical approaches to implement AI/ML solutions while meeting rigorous regulatory standards—perfect for staying ahead of compliance disruptions.
” Webinar 2: Clinical Data Management and Trial Master File Compliance Under FDA Standards (Sep 26, 2024)”
Description:
-
- This session delves into clinical data management and trial master file compliance—critical components of FDA-regulated research.
- Gain actionable insights on managing complex data sets, maintaining data integrity, and ensuring that your TMF meets regulatory standards.
- A timely course for clinical professionals aiming to refine their data strategies and stay compliant with evolving FDA expectations.
” Webinar 3: Lean Project Management for FDA-Regulated Environments: Principles and Applications (Sep 30, 2024)”
Description:
-
- Discover how to apply lean project management principles to FDA-regulated environments, optimizing efficiency while maintaining compliance.
- This course focuses on reducing waste, enhancing project workflows, and aligning with FDA standards.
- Ideal for project managers and team leaders looking to streamline documentation and processes as they drive compliance initiatives forward.
Join Now!
Why you should buy this pack
As we near year-end, regulatory landscapes are rapidly evolving, and staying ahead is no longer optional—it’s essential.
” This 3-course pack targets the latest challenges in AI/ML regulations, lean project management, and clinical data compliance, providing professionals with the advanced skills needed to navigate these complexities.”
Here’s why you need this pack:
-
- Prepare for AI/ML Regulatory Disruptions:
-
- With FDA’s increasing focus on AI/ML in clinical settings, this course helps you tackle compliance head-on, ensuring your innovative solutions meet regulatory standards without compromising on performance.
-
- Prepare for AI/ML Regulatory Disruptions:
-
- Streamline Your Project Management Approach:
-
- Lean methodologies are redefining how compliance projects are executed.
- Learn to reduce inefficiencies, eliminate waste, and drive faster outcomes that align with FDA requirements, saving time and resources.
-
- Streamline Your Project Management Approach:
-
- Master Clinical Data Management:
-
- As scrutiny on trial master files and clinical data intensifies, ensure your processes are robust, secure, and fully compliant.
- This course provides critical insights into managing data integrity and handling complex data sets with confidence.
-
- Master Clinical Data Management:
Why Each Course is a Crucial Component
-
- Navigating FDA Regulations for AI/ML:
-
- This course addresses unprecedented regulatory challenges for AI/ML applications in clinical environments, providing cutting-edge strategies to integrate compliance into your digital innovation journey.
-
- Navigating FDA Regulations for AI/ML:
-
- Lean Project Management for FDA-Regulated Environments:
-
- Modern project managers must adapt to lean techniques to optimize compliance workflows.
- This course helps you lead teams efficiently while meeting stringent regulatory expectations.
-
- Lean Project Management for FDA-Regulated Environments:
-
- Clinical Data Management and TMF Compliance:
-
- As FDA emphasizes data quality and integrity, understanding the latest standards in TMF compliance is crucial for any clinical research professional aiming to excel in today’s regulatory environment.
-
- Clinical Data Management and TMF Compliance:
This pack is your solution to addressing advanced compliance challenges—register now to gain the expertise needed to thrive in 2024’s complex FDA landscape.
Register Now!
As we near year-end, regulatory landscapes are rapidly evolving, and staying ahead is no longer optional—it’s essential.
” This 3-course pack targets the latest challenges in AI/ML regulations, lean project management, and clinical data compliance, providing professionals with the advanced skills needed to navigate these complexities.”
Here’s why you need this pack:
-
- Prepare for AI/ML Regulatory Disruptions:
-
- With FDA’s increasing focus on AI/ML in clinical settings, this course helps you tackle compliance head-on, ensuring your innovative solutions meet regulatory standards without compromising on performance.
-
- Prepare for AI/ML Regulatory Disruptions:
-
- Streamline Your Project Management Approach:
-
- Lean methodologies are redefining how compliance projects are executed.
- Learn to reduce inefficiencies, eliminate waste, and drive faster outcomes that align with FDA requirements, saving time and resources.
-
- Streamline Your Project Management Approach:
-
- Master Clinical Data Management:
-
- As scrutiny on trial master files and clinical data intensifies, ensure your processes are robust, secure, and fully compliant.
- This course provides critical insights into managing data integrity and handling complex data sets with confidence.
-
- Master Clinical Data Management:
Why Each Course is a Crucial Component
-
- Navigating FDA Regulations for AI/ML:
-
- This course addresses unprecedented regulatory challenges for AI/ML applications in clinical environments, providing cutting-edge strategies to integrate compliance into your digital innovation journey.
-
- Navigating FDA Regulations for AI/ML:
-
- Lean Project Management for FDA-Regulated Environments:
-
- Modern project managers must adapt to lean techniques to optimize compliance workflows.
- This course helps you lead teams efficiently while meeting stringent regulatory expectations.
-
- Lean Project Management for FDA-Regulated Environments:
-
- Clinical Data Management and TMF Compliance:
-
- As FDA emphasizes data quality and integrity, understanding the latest standards in TMF compliance is crucial for any clinical research professional aiming to excel in today’s regulatory environment.
-
- Clinical Data Management and TMF Compliance:
This pack is your solution to addressing advanced compliance challenges—register now to gain the expertise needed to thrive in 2024’s complex FDA landscape.
Register Now!
Webinar Pack Agenda
WEBINAR 1: Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Required Number of Participants
- Choice of Tasks to Validate
- Qualitative Success Criteria
- Validation Protocol
- Post-Test Participant Inquiry (Includes Usability Validation Tracking Matrix)
- Validation Test Results Report (Provided as Handouts)
WEBINAR 2: Clinical Data Management and Trial Master File Compliance Under FDA Standards
-
- Trial Master File (TMF) Overview:
-
- Understand the Background and Rationale behind TMF to grasp its Critical Role in clinical trials.
-
- Trial Master File (TMF) Overview:
-
- TMF Content Requirements:
-
- Learn precisely What Content Is Essential for a TMF in a clinical trial.
-
- TMF Content Requirements:
-
- Essential Documents:
-
- Identify the Key Documents that must be included in a TMF and their role in demonstrating the Regulated Activities of both the investigator and sponsor.
-
- Essential Documents:
-
- TMF Organization and Maintenance:
-
- Discover strategies for effectively Organizing and Maintaining your TMF for Ease of Access and Compliance.
-
- TMF Organization and Maintenance:
-
- Quality Assurance:
-
- Learn how to ensure the Quality and Accuracy of the data within your TMF.
-
- Quality Assurance:
-
- Standard Operating Procedures (SOPs):
-
- Understand the SOPs Required to support and enhance TMF management.
-
- Standard Operating Procedures (SOPs):
-
- Document Location System:
-
- Develop a Consistent and Efficient System for locating TMF documents quickly.
-
- Document Location System:
-
- Regulatory Inspection Preparedness:
-
- Prepare for Regulatory Inspections by ensuring your TMF records are Compliant and readily accessible.
-
- Regulatory Inspection Preparedness:
-
- Industry Standards and Best Practices:
-
- Explore the Latest Industry Standards and Best Practices to keep your TMF Up-to-Date and Compliant.
-
- Industry Standards and Best Practices:
-
- Interactive Q&A Session:
-
- Engage with Experts and Peers in an Interactive Q&A Session to discuss specific challenges and solutions.
-
- Interactive Q&A Session:
WEBINAR 3: Lean Project Management for FDA-Regulated Environments: Principles and Applications
-
- Introduction to Principles of Lean Documents and Lean Configuration
- Principles of Project Management Based on Critical Chain Concepts
- Discovery Phase and the Importance of Proper Gap Analysis
- Design Control Phases for the Project:
- Design & Development Plan as Part of the Definition Phase
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Incorporating the Build Phase After Design Review as the Basis for Design Verification and Design Validation
- Conclusions
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.
WEBINAR 1: Navigating FDA Regulations for AI/ML in Clinical Settings
-
- Required Number of Participants
- Choice of Tasks to Validate
- Qualitative Success Criteria
- Validation Protocol
- Post-Test Participant Inquiry (Includes Usability Validation Tracking Matrix)
- Validation Test Results Report (Provided as Handouts)
WEBINAR 2: Clinical Data Management and Trial Master File Compliance Under FDA Standards
-
- Trial Master File (TMF) Overview:
-
- Understand the Background and Rationale behind TMF to grasp its Critical Role in clinical trials.
-
- Trial Master File (TMF) Overview:
-
- TMF Content Requirements:
-
- Learn precisely What Content Is Essential for a TMF in a clinical trial.
-
- TMF Content Requirements:
-
- Essential Documents:
-
- Identify the Key Documents that must be included in a TMF and their role in demonstrating the Regulated Activities of both the investigator and sponsor.
-
- Essential Documents:
-
- TMF Organization and Maintenance:
-
- Discover strategies for effectively Organizing and Maintaining your TMF for Ease of Access and Compliance.
-
- TMF Organization and Maintenance:
-
- Quality Assurance:
-
- Learn how to ensure the Quality and Accuracy of the data within your TMF.
-
- Quality Assurance:
-
- Standard Operating Procedures (SOPs):
-
- Understand the SOPs Required to support and enhance TMF management.
-
- Standard Operating Procedures (SOPs):
-
- Document Location System:
-
- Develop a Consistent and Efficient System for locating TMF documents quickly.
-
- Document Location System:
-
- Regulatory Inspection Preparedness:
-
- Prepare for Regulatory Inspections by ensuring your TMF records are Compliant and readily accessible.
-
- Regulatory Inspection Preparedness:
-
- Industry Standards and Best Practices:
-
- Explore the Latest Industry Standards and Best Practices to keep your TMF Up-to-Date and Compliant.
-
- Industry Standards and Best Practices:
-
- Interactive Q&A Session:
-
- Engage with Experts and Peers in an Interactive Q&A Session to discuss specific challenges and solutions.
-
- Interactive Q&A Session:
WEBINAR 3: Lean Project Management for FDA-Regulated Environments: Principles and Applications
-
- Introduction to Principles of Lean Documents and Lean Configuration
- Principles of Project Management Based on Critical Chain Concepts
- Discovery Phase and the Importance of Proper Gap Analysis
- Design Control Phases for the Project:
- Design & Development Plan as Part of the Definition Phase
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Incorporating the Build Phase After Design Review as the Basis for Design Verification and Design Validation
- Conclusions
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 webinar pack for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- AI/ML Specialists: Facing compliance hurdles with integrating AI/ML in clinical settings.
- Regulatory Affairs Managers: Needing insights on new FDA regulations for digital technologies.
- Project Managers: Struggling to streamline projects under strict FDA regulatory requirements.
- Clinical Data Managers: Addressing challenges in maintaining data integrity and TMF compliance.
- Compliance Officers: Navigating complex and evolving FDA standards in regulated environments.
- Lean Process Consultants: Seeking to optimize documentation and processes within FDA frameworks.
- Quality Assurance Professionals: Ensuring advanced compliance with clinical data and AI-driven systems.
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- AI/ML Specialists: Facing compliance hurdles with integrating AI/ML in clinical settings.
- Regulatory Affairs Managers: Needing insights on new FDA regulations for digital technologies.
- Project Managers: Struggling to streamline projects under strict FDA regulatory requirements.
- Clinical Data Managers: Addressing challenges in maintaining data integrity and TMF compliance.
- Compliance Officers: Navigating complex and evolving FDA standards in regulated environments.
- Lean Process Consultants: Seeking to optimize documentation and processes within FDA frameworks.
- Quality Assurance Professionals: Ensuring advanced compliance with clinical data and AI-driven systems.
Instructors Profile
Speaker 1: José Mora – 2 Courses in the pack
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Speaker 2: Carolyn (McKillop) Troiano – 1 Course in the pack
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.
