Workshops

 

OUR WORKSHOP MISSION

Live Oak Workshops are designed to equip you with the knowledge and critical thinking strategies that lead to success in the advancement of your GXP career.  As worldwide regulatory expectations in the world of data integrity and data governance change, our workshops prepare you for with the skills necessary to interpret regulations, guidance, and regulatory action into simple approaches for managing your everyday GXP responsibilities with the efficiency needed to thrive. 

Sign up now to join us as we discuss, debate, question, and tackle interesting regulatory case studies in the world of data integrity and data governance!

 

Stage 1 — Fundamentals of GXP Data Integrity/Governance

The Stage 1 workshop is focused on developing a solid understanding of the foundations of GXP data science and data integrity assurance. In this two-day workshop, we discuss current regulatory expectations and guidance, with the goal of developing a comprehensive understanding of how to operate efficiently within a GXP regulated environment. We discuss risk-based approaches to ensure regulatory compliance; referencing current regulations, regulatory actions, and harmonized guidance. Specific sub-topics include:

  • A modern interpretation of 21 CFR Part 11/EU Annex 11

  • FDA GMP regulation 21 CFR Part 211.68 – computerized systems in GMP

  • PIC/s Final Guidance (June 2021): Data Integrity

  • Quality Risk Management:

    o Design

    o Operation

    o Monitoring

  • Strategies for metadata (e.g. audit trail) review

  • Critical Thinking and Data Integrity

Each day will include hands-on case studies (in-person or in virtual breakout rooms) where participants will practice the application of data integrity principles in real-life scenarios.

The Stage 1 workshop is designed for personnel engaged in regulated GXP activities (employees who create, review or approve GXP data). This workshop moves beyond the ALCOA+ principles with a heavy emphasis on quality risk management and is relevant to both new and experienced employees as we discuss data integrity from a regulator’s perspective. This workshop is designed to set individuals up for success in an evolving regulatory environment that is rapidly adapting to new technologies.

Each topic is presented and discussed from a regulatory patient-focused perspective, with one objective being gaining the confidence necessary to address complicated questions (e.g., hybrid systems) during regulatory inspections and/or internal audits. When employees are able to confidently describe “why we do what we do” from a risk-based and patient-centric perspective, inspectors are better able to understand the site’s rationale, reducing misunderstandings and ultimately leading to improved regulatory/audit outcomes.

Who should join the Stage 1 Fundamentals course? Individuals working within a GXP environment that:

  • are required to operate efficiently within a regulated environment (QC, Manufacturing, Quality, Warehouse, etc.) where the integrity of data (paper or electronic) is considered critical to patient safety,

  • may (or are) tasked with contributing to investigations (e.g., deviations) that include data integrity concerns,

  • perform or participate in internal or external audits,

  • participate in computer system validation activities,

  • field data integrity-related questions (written or verbal) during regulatory or customer interaction

Stage 2 — Thought Leader / Expert

In this two-day stage 2 thought leader course, we discuss intermediate and advanced GXP data integrity and data governance concepts, with the goal of preparing individuals for success in an ever-evolving technology and regulatory landscape. This is an intermediate/advanced workshop that includes ~50% lecture and ~50% hands-on individual and group problem-solving. Participants will be challenged to apply critical thinking in the context of GXP data integrity through discussion and debate and will be equipped with the experience and insight necessary to operate as a thought leaders in the area of data governance within their organization. Thought leaders will gain the background necessary to:

  1. apply critical thinking during the assessment of new or existing processes to determine if the level of residual risk is acceptable,

  2. participate in the planning and execution of a data governance strategy in compliance with regulatory expectations, and

  3. seamlessly integrate quality risk management within the data integrity/data governance compliance plans

Who should join the Stage 2 Thought Leader course? Individuals working within a GXP environment that:

  • are required to operate efficiently within a regulated environment where the integrity of data (paper or electronic) is considered critical to patient safety

  • may (or are) tasked with handling investigations (e.g., deviations) that include data integrity concerns,

  • perform or participate in internal or external audits,

  • participate in computer system validation activities,

  • field data integrity-related questions (written or verbal) during regulatory or customer interaction,

Stage 3 — Data Integrity/Governance Influencer

In this one-day stage 3 influencer course, we discuss effective techniques to influence meaningful and effective change within an organization’s data integrity/data governance strategy. This is an advanced workshop using train-the-trainer methodology; participants will gain the insight necessary to develop and communicate patient-centric solutions for the future based on a foundation of regulatory compliance. Insights gained from Stage 1 and 2 workshops will be combined to develop a “subject matter expert” approach to data science within a GXP environment. Influencers will gain the background necessary to:

  1. develop risk-based strategies for large-scale shifts in corporate/business data integrity resources,

  2. develop and execute employee training programs tailored to the evolving regulatory landscape, and

  3. quickly and effectively field questions or concerns during interaction with regulators/customers.

Who should join the Stage 3 Influencer course? Individuals working within a GXP environment that:

  • Plan, develop, and/or execute employee training in the area of data integrity/data governance,

  • Field data integrity-related questions (written or verbal) during regulatory or customer interaction

  • Plan, develop, and/or influence change with a site/business data governance strategy