Instructor: Shannon Hoste

Learning Objectives:

1. Define a Medical Device​

2. Exposure to Design & Development Process​

3. Understand the difference between Verification and Validation​

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Instructor: Shannon Hoste

Learning Objectives:

1. Discussion of Risk Based Classifications for Software as a Medical Device​

2. Introduction to Post Market Surveillance for Medical Device​

3. Introduction to Risk and Investigation for Medical Device​

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Instructor: Shannon Hoste

Learning Objectives:

1. Awareness of the terminology behind human subject research and privacy​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the criticality of a well-prepared clinical plan​

2. Understand the goals of the different clinical trial phases​

3. Understand the difference between a feasibility study and a pivotal study. ​

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Instructor: Shannon Hoste

Learning Objectives:

1. Explain historical aspects of drug and device clinical trials​

2. Introduction to regulatory authority oversight and guidance for clinical studies​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Examine the studies needed to support claims made on labels.​

2. Understand the role of stability studies.​

3. Realize the steps needed to counteract counterfeit

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Instructor: Shannon Hoste

Learning Objectives:

1. Provide an overview of various types of validation: equipment, product and process.​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Review US market medical device pathways.​

2. Understand the structure and actions of FDA during submissions.

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Introduction to the product development lifecycle​

2. Understand the intricacies of cross-functional alignment throughout development​

3. Learn the criticality of risk identification, evaluation and mitigation​

4. Exposure to the usefulness of the stage gate process​

5. Understand the complexity of validating a process​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Delve into the impact of storage conditions.​

2. Explore the challenges with transit conditions.​

3. Understand the importance and role of packaging.​

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Instructors: Bill Brodbeck

Learning Objectives:

1. Awareness of regulatory requirements around Design Inputs​

2.Understand the importance of user needs identification​

3. Define what it means to write good requirements​

4. How to write/translate user needs into design input requirements​

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Instructors: Bill Brodbeck

Learning Objectives:
1. Awareness of regulatory requirements around Design Outputs​

2. Understand the relationship between Design Inputs and Design Outputs​

3. Awareness of the multiple sources of Design Outputs across the design and development life cycle.

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Recognize the impact of the supply chain on patient safety​

2. Understand a Paradigm shifting view of supply chain failures​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Learn how to gain internal alignment on requirements of your suppliers that are important to you​

2. Align on how well your suppliers meet your requirements​

3. Understand the criticality of alignment prior to selecting a supplier and for on-going assessment of the supplier

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. How to align internally on supply chain criteria​

2. How, when and why to engage the supplier​

3. Understand the role and criticality of self-qualification​

4. Understand the benefits of relationship risk mapping​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand how clinical trial outcomes can be biased, misinterpreted, and not understood.​

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Instructor: Shannon Hoste

Learning Objectives:

1. Explore a case study for design of a clinical trial.​

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Instructor: Shannon Hoste

Learning Objectives:

1. Provide an overview of various types of validation:  cleaning and computer systems.

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Instructor: Shannon Hoste

Learning Objectives:

1. Exposure to what manufacturing in the medical device industry looks like​

2. Introduction into the controls needed for consistent product outcomes.​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1.Envision the total qualification process​

2. Understand key aspects of Installation Qualification and Operational Qualification​

3. Explore the qualification of an eye drop filler process​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Overview of Medical Device Design and Development​

2. Understand the Concept Phase of Design and its role in Design and Development​

3. Understand the role of Regulatory Affairs in the Concept Phase​

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Instructors: Bill Brodbeck

Learning Objectives:

1. Understand the Design Planning Phase of Design and Development​

2. Overview of Design and Development Files​

3. Understand the role of Regulatory Affairs in the Planning Phase of Design and Development ​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Identify the regulatory requirements for Design Reviews​

2. Understand when Design Reviews should be conducted and what they should cover​

3. Discuss lessons learned for conducting effective design reviews​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Understanding of Verification vs. Validation​

2.Exposure to the processes that are coming together within a Verification & Validation Phase of Medical Device Development​

3. Define and explore Design Verification activities​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Further understanding of Verification vs. Validation​

2. Understand that the scope of Design Validation includes evaluation of production units or equivalent​

3. Define and explore Design Validation activities​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand production and process control requirements.​

2. Consider Process Validation practices for medical device manufacturing.​

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Instructor: Shannon Hoste

Learning Objectives:

1. Close out discussion on Stage-gate Model​

2. Understand the types of decisions made during stage gate models that relate to the product, process, business and patient​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the ways in which computer systems support operations and decision making

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand what needs to be done to protect computerized data and information

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Instructor: Shannon Hoste

Learning Objectives:

1. Explore examples of enforcement actions at various levels ​

2. Consider different perspectives in these activities​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the gap between clinical trial and real-world data​

2. Identify passive and active data collection methods​

3. Learn regulatory reporting requirements​

4. Explore AI-powered surveillance techniques​

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Instructors: Bill Brodbeck

Learning Objectives:

1. Define Design Transfer.​

2. Identify the Design Transfer activities occurring in Design Input, Output and V&V phases of development.​

3. Consider how to trace key safety-related Design Transfer activities within the Risk Management File​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand regulatory requirements for computer system validation (CSV)/ Computer Software Assurance (CSA)​

2. Understand the process​

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Instructor: Shannon Hoste

Learning Objectives:

1. Become aware of the evolving technological and regulatory science landscape around Digital Health​

2. Learn about the different aspects & considerations within Digital Health, such as cybersecurity vulnerabilities

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Instructor: Marla Phillips

Learning Objectives:

1. Understand how AI works behind the scenes in the world of imaging​

2. How to transform our concept of validation to a system that constantly changes​

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Instructor: Marla Phillips

Learning Objectives:

1. Understand how 3D printing is and can be used in the health care industry​

2. Exposure to regulatory guideline approaches to keeping up with the pace of innovation​

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Instructor: Bill Brodbeck

Learning Objectives:

1. Understand the requirements and process for change control.​

2. Understand the required reviews and documentation dependent on the phase in which design changes occur. ​

3. Review regulatory submission pathways.​

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Instructor: Marla Phillips

Learning Objectives:

1. Development Journey: Looking at design controls through the lens of an epinephrine auto-injector story​

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