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. 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: Shannon Hoste

Learning Objectives:

1. Review of the various types of drug approval pathways depending on product type​

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Instructor: Shannon Hoste

Learning Objectives:

1. Review of the various types of drug approval pathways depending on product type​

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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. 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 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. 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: Shannon Hoste

Learning Objectives:

1. Clinical Trial Design Strategies​

2. Clinical phases ​

3. Clinical trial terminology​

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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. 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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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. Why analytical methods need to be validated​

2. The existence of pharmacopeial and non- pharmacopeial methods​

3. Exposure on how to validate analytical methods​

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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: 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: 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.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. 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: 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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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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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: Marla Phillips

Learning Objectives:

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

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