Instructor: Shannon Hoste

Learning Objectives:

1. Demonstrate why we have regulations​

2. Understand the challenges in developing regulations that will effectively protect lives

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the challenges in developing regulations that will effectively protect lives​

2. Consider how a Regulatory Authority can structure to define, monitor and enforce regulations.​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the mission of a Regulatory Authority​

2. Recognize the potential complexities of

regulatory pathways​

3. Gain familiarity with the U.S. FDA authority​

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Instructor: Shannon Hoste

Learning Objectives:

1. Recognize the global landscape of regulations, through a few examples​

2. Understand the importance of good quality practices​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand how global agencies are working together​

2. Understand how harmonization is beneficial to industry​

3. Understand where our industry and patients are still vulnerable​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Provide a viewpoint of how a systems approach drives successful outcomes​

2. Understand how systems enable consistency​

3. Recognize the criticality of Management Total Ownership​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand how systems support successful product development​

2. Recognize the distinction between product development and realization​

3. Understand how to group processes into systems to increase success​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Scenario 1: Follow the development of a product through the Total Product Life Cycle of Systems​

2. Scenario 2: Understand how systems work when a Contamination Control Failure occurs​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Striving for "compliance" is not sufficient to ensure good product quality.​

2. Striving for good quality requires strong leadership and culture.​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Recognize that change can have an impact on the safety and effectiveness of the product.​

2. Understand that the risk the change might have on patients dictates the requirements needed for change approval​

3. Explore the differences between pharma and device changes​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand how FDA determines who to inspect​

2. Exposure to how FDA organizes their inspections through a systems approach​

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Instructor: Shannon Hoste

Learning Objectives:

1. Learn to think like an FDA investigator and see a facility the way an investigator does.​

2. Learn to write investigational findings​

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Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand the enforcement tools regulators have at their disposal to protect population health.​

2. Understand how global regulatory agencies work together to impose enforcement actions that impact worldwide market access.​

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the similarities and differences of legal authority for mandating recalls across the FDA and global agencies.​

2. Exposure to the recall process and risk factors​

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Instructor: Marla Phillips

Learning Objectives:

1. Standard Operating Procedures provide clear, consistent instructions for how all employees must perform specific functions so there is a consistent outcome.

2. Standard Operating Procedures are difficult to write such that they are interpreted consistently by every employee.

3. The failure to write clear and concise procedures leads to an increased opportunity for failure and risk.

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Instructor: Marla Phillips

Learning Objectives:

1. Writing great procedures is important, but effective training will increase the likelihood of success for your employees, your company and the patients you serve.

2. The level of training should be commensurate with the need.

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