A Tactical Approach to Implementing CSA in Your Organization


Thursday, September 22 | 11:00AM ET 

Presented by: Scott Cady, Senior IT Quality & Compliance Consultant, Azzur Group

This session focuses on the experienced validator’s new role in the SDLC process. Designed for seasoned Validation and Quality professionals with a general understanding of the CSA concepts (i.e., risk-based approach) and versed in performing GAMP-based requirement risk assessments. Some CSV/QA professionals are concerned that FDA’s Case for Quality (CfQ) and ISPE’s Computer Software Quality (SQA) initiatives will force them out of the job market. With CSA, the validator’s role transitions from goalie to coach. So, how do you become a coach?

Additionally, the session provides steps you can take now to reduce validation costs and timelines without revising your existing Quality Management System, Master Validation Plan, Validation/Quality/DI Policies, and SOPs. Using the techniques shown, you can seamlessly integrate CSA methods into your validation efforts to reduce the time and costs associated with validation work.

Key Takeaways:

  • Enhancing your Supplier Quality Audits and Service-Level Agreements
  • Obtaining Stakeholder (SME) involvement
  • Utilizing the Requirements Traceability Matrix as the backbone for CSA implementation in your organization

SPEAKERS


Scott Cady

Senior IT Quality & Compliance Consultant, Azzur Group


Mr. Cady has an impressive 20 years’ experience in leading cutting-edge IT improvement initiatives and has been made noteworthy by translating executive vision into sweeping reforms to streamline operations and reduce costs in keeping organizations viable in fiercely competitive markets.

Scott is well-respected as a leader in galvanizing teams to embrace a singular vision and oneness of purpose coupled with a deep commitment to staff training and mentoring.

With a winning personality and approachable manner, Scott serves as a powerful influencer amongst business executives, opinion drivers, and key stakeholders and have an impressive history in providing exceptional customer service and client support.

As a champion of securing consensus, Scott is regarded for building and maintaining strong working relationships with business executives, vendors, key stakeholders, and opinion drivers.

He is also highly regarded for delivering sophisticated projects on-time and within budget despite demanding expectations, shifting priorities, ambiguities, and stringent deadlines.


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