Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Exposure to the overall drug development process​

2. Understand the criticality of studying formulation and process​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Exposure to the role and function of various excipients​

2. Overview of typical manufacturing process steps​

3. Understand how to develop the process for the intended product function/needs​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the Quality Target Product Profile​

2. Explain what “Design Space” is and why it is important to study/develop​

3. Become familiar with what is “critical”

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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: 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: Marla Phillips, Ph.D.

Learning Objectives:

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

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

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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. Understand the Quality Target Product Profile​

2. Explain what “Quality by Design” is and why it is important to study/develop​

3. Become familiar with what is “critical”​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the impact of material variability on the critical quality attributes of the final product​

2. Become exposed to ways of assessing the criticality of material attributes​

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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: Marla Phillips, Ph.D.

Learning Objectives:

1. Recognize the criticality of technology and knowledge transfer​

2. Exposure to validation through a tablet and IV product case studies​

3. Understand how to handle failures during validation​

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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: 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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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 production and process control requirements.​

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

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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. 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: Marla Phillips, Ph.D.

Learning Objectives:

1. Learn where drug discovery starts​

2. Understand how lead compounds are identified​

3. Identify considerations for successful drug products​

4. Key tools used in QbD

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the criticality of process design and development​

2. Learn what scientists study to ensure the process will generate the intended

product (every time)​

3. See how the QTPP, CQAs, CMAs and CPPs are put into action

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the criticality of process design and controls for successful product outcomes​

2. Recognize the level of rigor that goes into developing the design space​

3. Explore the process considerations for different product types​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand what affects the expiration of your product.​

2. Learn how to develop your product with stability in mind.​

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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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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Why perform stability studies​

2. How to run a stability program​

3. What constitutes a stability failure and how to report it​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the complexities of cleaning equipment​

2. Exposure to different sampling techniques​

3. Introduction to acceptance criteria​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Introduction to Media Fill Trials​

2. Exposure to critical aspects involved in Media Fill Trials​

3. Understand how to assess the outcome of Media Fill Trials​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand how to verify the validated state of the process on an ongoing basis​

2. Learn how our R&D work has prepared us for commercial production​

3. Understand how to use AQL sampling tables​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the significance of how change is managed using ICH Q12​

2. Learn what Established Conditions are, and how they are linked to Quality by Design Studies​

3. Review the filing outcomes of several scenarios​

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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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