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: 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: 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: Shannon Hoste

Learning Objectives:

1. Explore aspects of ALCOA++ ​

2. Consider our individual responsibilities for data integrity.​

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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. Good documentation practices are critical to ensuring your product is safe and effective.

2. You cannot rely on memory to keep track of what was done.

3. Documentation is needed to prove everything was done correctly.

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Instructor: Marla Phillips

Learning Objectives:

1. Understand what is considered as “good documentation practices”

2. Learn how poor documentation practices can impact the product and the business.

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R17b: Access the Class —>

R17c: Access the Class —>

R17d: Access the Class —>

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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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: 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. 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​

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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

Learning Objectives:

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

the product itself​

2. Use of control charts for on-going monitoring​

3. Goal is to become predictive​

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Instructor: Jennifer Ahearn (ESi, former FDA)

Learning Objectives:

1. What does “Data Integrity” mean?

2. Understand the principles of ALCOA Plus

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Instructor: Jennifer Ahearn (ESi, former FDA)

Learning Objectives:

1. Understand examples of data integrity breaches

2. Recognize the implications of data integrity breaches

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Instructor: Jennifer Ahearn (ESi, former FDA)

Learning Objectives:

1. Deeper understanding of what is included in “Data”

2. Expectations for Data Integrity failure investigations

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Instructor: Jennifer Ahearn (ESi, former FDA)

Learning Objectives:

1. Understand the complexities of electronic data management

2. Recognize that your data is one of the greatest assets your company owns

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Instructor: Jennifer Ahearn (ESi, former FDA)

Learning Objectives:

1. Data Integrity assurance should be commensurate with the risk.

2. Understand what is meant by data flow, and how to use that knowledge.

3. Identify critical steps in your operations that require increased data integrity assurance.

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Instructor: Chris Chaney (Elanco) and Brent Conatser (Elanco, former FDA)

Learning Objectives:

1. Dive into how to find data integrity breaches during a Data Integrity Audit

2. Learn how to take a systems approach to the audit

3. Understand what to verify

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Instructor: Chris Chaney (Elanco) and Brent Conatser (Elanco, former FDA)

Learning Objectives:

1. Identify data integrity concerns while conducting GMP audits

2. Learn how to respond to what is found

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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: 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. 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. 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​

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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: Bill Brodbeck

Learning Objectives:

1. Overview of Medical Device Design and Development​

2. Understand the Concept Phase of Design and its role in Design and Development​

3. Understand the role of Regulatory Affairs in the Concept Phase​

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Instructors: Bill Brodbeck

Learning Objectives:

1. Understand the Design Planning Phase of Design and Development​

2. Overview of Design and Development Files​

3. Understand the role of Regulatory Affairs in the Planning Phase of Design and Development ​

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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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Instructor: Bill Brodbeck

Learning Objectives:

1. Understand the concepts and terminology of risk.​

2. Be familiar with methods to identify, evaluate, control and manage device risks.​

3. Understand the components and purpose of the living documents within a risk management file. ​

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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. Identify the regulatory requirements for Design Reviews​

2. Understand when Design Reviews should be conducted and what they should cover​

3. Discuss lessons learned for conducting effective design reviews​

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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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Instructor: Bill Brodbeck

Learning Objectives:

1. Further understanding of Verification vs. Validation​

2. Understand that the scope of Design Validation includes evaluation of production units or equivalent​

3. Define and explore Design Validation 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: 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: Bill Brodbeck

Learning Objectives:

1. Understand the requirements and process for change control.​

2. Understand the required reviews and documentation dependent on the phase in which design changes occur. ​

3. Review regulatory submission pathways.​

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Instructor: Marla Phillips

Learning Objectives:

1. Understand how to react to failure appropriately.

2. Introduction to investigative methodology.

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Instructor: Scott Doucherty and Neil Lewis

Learning Objectives:

1. Tools that can help in writing an objective and complete problem statement.

2. The importance of identifying the true root cause in any investigation

3. Human Error is not a root cause. It can be a contributing factor.

4. Interviewing employees gives great insight into failure events.

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R07b: Access the Class —>

R07c: Access the Class —>

Instructors: Scott Docherty and Neil Lewis

Learning Objectives:

1. Understand two failure investigation tools and their use to get to root cause.

2. Understand the importance of identifying root cause in any investigation

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R08b: Access the Class —>

Instructors: Scott Docherty and Neil Lewis

Learning Objectives:

1. Put the investigation tools, learned previously, into practice.

2. Understand how to assess the breadth and depth of impact that a failure can have.

3. Identify ways to correct failure, prevent failure, and determine the effectiveness of those actions.

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Instructor: Marla Phillips

Learning Objectives:

1. Compare “what not to do” versus what you have learned about proper investigation management

2. Understand the broad impact of poor investigation studies

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Instructor: Marla Phillips

Learning Objectives:

1. Explore the intricacies of different failure scenarios

2. Pull everything together you have learned so far to assess the situation and conclude the investigation

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Instructor: Marla Phillips

Learning Objectives:

1. Good documentation practices are critical for knowledge retention for your business.

2. Intentional falsification of records is a criminal offense.

3. Poor documentation practices have to be investigated to understand the full impact, including the people, timeframe and products involved.

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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: 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. 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: 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: Shannon Hoste

Learning Objectives:

1. Important Aspects of Post-Market Surveillance​

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

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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: Bill Farmer (Merck)

Learning Objectives:

1. Learn how to identify poor root cause identification

2. Understand the importance of finding true root cause

3. Understand the link between root cause identification and effective CAPA development

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Instructor: Bill Farmer (Merck)

Learning Objectives:

1. Recognize the Difference between Corrections, Corrective Actions and Preventative Actions.

2. Measure the Strength of your CAPA.

3. Understand Risk Factors to determine the CAPA strength needed.

4. Keep the “line of sight” from problem, to cause, to CAPA

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Instructor: Ann Moody (CSL Behring)

Learning Objectives:

1. Learn the impact of “retraining” employees.

2. Understand that Human Error is not a root cause.

3. How to properly address failures that resulted in a human error, and prevent recurrence.

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Instructor: Bill Farmer (Merck)

Learning Objectives:

1. Learn how to breakdown the CAPA development process into steps

2. Understand the different levels of assessing CAPA effectiveness

3. Realize the importance of Knowledge Management, and how to capture this knowledge

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Instructor: Bill Farmer (Merck)

Learning Objectives:

1. Reinforce your learning on how to develop SMART CAPA and verify effectiveness.

2. We will review 3 scenarios

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