Instructor: Shannon Hoste

Learning Objectives:

1. Demonstrate why we have regulations​

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

Access the Class —>

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.​

Access the Class —>

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​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

2. Understand the importance of good quality practices​

Access the Class —>

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​

Access the Class —>

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​

Access the Class —>

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​

Access the Class —>

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​

Access the Class —>

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​

Access the Class —>

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

Access the Class —>

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​

Access the Class —>

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.​

Access the Class —>

Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Exposure to the overall drug development process​

2. Understand the criticality of studying formulation and process​

Access the Class —>

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​

Access the Class —>

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”

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

1. Define a Medical Device​

2. Exposure to Design & Development Process​

3. Understand the difference between Verification and Validation​

Access the Class —>

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​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

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. ​

Access the Class —>

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​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Bill Brodbeck

Learning Objectives:

1. Review US market medical device pathways.​

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

Access the Class —>

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.​

Access the Class —>

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.​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

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

Access the Class —>

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​

Access the Class —>

Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Metrics help give visibility into the performance of various operations and the product itself​

2. Introduction to basic metrics that can be used across the product lifecycle​

Access the Class —>

Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand what artificial intelligence is​

2. Understand examples of how artificial intelligence can be used​

3. Understand how employees can trust the artificial intelligence outcome​

Access the Class —>

Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Understand what culture is​

2. Understand how to affect the desired culture across the organization​

3. Understand how culture impacts the quality of the product​

Access the Class —>

Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Recognize when an investigation is needed​

2. Introduction to risk categorization for failures​

3. To understand the basics of how to conduct and write a failure investigation​

4. Take you on a journey that uncovers common pitfalls​

Access the Class —>

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​

Access the Class —>

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​

Access the Class —>

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.​

Access the Class —>

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​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

1. Explore examples of enforcement actions at various levels ​

2. Consider different perspectives in these activities​

Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

1. Important Aspects of Post-Market Surveillance​

2. Understand what active and passive surveillance means and why both are required​

Access the Class —>