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: 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.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. 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. 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: 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. 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. 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. 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. 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: 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. 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 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 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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