Upcoming Events

• 

  
  1 day to the event

  Wed, 04 Mar

  Risk Management Integration: ISO 14971 in a QMSR World / 

  Virtual Events

  Complete Information

  04 Mar 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: John E. Lincoln How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and ICH Q9 under the new device QMSRs.
• 

  
  2 days to the event

  Thu, 05 Mar

  Leveraging AI in Risk Assessment for Smarter Computer Systems Validation / 

  Virtual Events

  Complete Information

  05 Mar 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Carolyn Troiano This course shows how AI can be applied responsibly to risk assessment in computer systems validation, replacing static scoring with evidence-driven decisions.
• 

  
  16 days to the event

  Thu, 19 Mar

  Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device / 

  Virtual Events

  Complete Information

  19 Mar 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: José Mora Test method validation is an often confusing requirement for medical devices.
• 

  
  October 23 - 24, 2025 | Time: 10AM to 4PM

  Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS / 

  Virtual Events

  Complete Information

  October 23 - 24, 2025 | Time: 10AM to 4PM

  Virtual Events

  Faculty: JOSÉ MORA Medical device manufacturers face growing challenges in design controls, process validation, and regulatory compliance, often leading to inefficiencies, redundancies, and compliance risks.
• 

  
  October 27 - 28, 2025 | Time: 9AM to 2PM

  Aseptic Processing and Validation Course - FDA Expectations and Industry Best Practices / 

  Virtual Events

  Complete Information

  October 27 - 28, 2025 | Time: 9AM to 2PM

  Virtual Events

  Faculty: MEREDITH CRABTREE This course provides an in-depth review of process design, contamination control strategy, risk assessments, and validation approaches aligned with FDA’s Guidance for Industry, EU Annex 1, and ICH Q9/Q10 principles.
• 

  
  Dec17-18, 2025 | Time: 10AM - 4PM

  Design of Experiments 101 - Methods and Analysis / 

  Virtual Events

  Complete Information

  Dec17-18, 2025 | Time: 10AM - 4PM

  Virtual Events

  Faculty: Elaine Eisenbesz Design of Experiments (DoE) provides a structured approach to investigate relationships between variables, eliminating guesswork of what is important, leading to reliable outcomes.
• 

  
  Oct 16- 17, 2025 | Time: 9AM - 2PM

  FDA Inspections - Top FDA 483 Observations and Prevention Strategies / 

  Virtual Events

  Complete Information

  Oct 16- 17, 2025 | Time: 9AM - 2PM

  Virtual Events

  Faculty: MEREDITH CRABTREE This expanded training provides an in-depth analysis of FDA inspection processes, common observations, and prevention strategies.
• 

  
  Dec10-11, 2025 | Time: 10AM - 3PM

  Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities / 

  Virtual Events

  Complete Information

  Dec10-11, 2025 | Time: 10AM - 3PM

  Virtual Events

  Faculty: Carolyn Troiano This seminar is a must-attend for professionals aiming to master CSA implementation for GxP systems. Transitioning to CSA offers transformative benefits, but it demands a clear understanding of regulatory expectations, risk-based strategies, and effective documentation.
• 

  
  Thu, 26 Feb

  Calculations for Process and Product Capability / 

  Virtual Events

  Recording Available

  26 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Elaine Eisenbeisz Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits.
• 

  
  Wed, 25 Feb

  Analytical Method Validation under Good Laboratory Practices (GLPs) / 

  Virtual Events

  Recording Available

  25 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Dr. John C. Fetzer‎ Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. GLP much like GMP ensures a comprehensive system that guarantees validity of results and overall quality.
• 

  
  Tue, 24 Feb

  Process Validation Requirements and Compliance Strategies / 

  Virtual Events

  Recording Available

  24 Feb 2026, 11:00 am – 12:00 pm GMT-5

  Virtual Events

  Faculty: José Mora This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.
• 

  
  Mon, 23 Feb

  FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality / 

  Virtual Events

  Recording Available

  23 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: John E. Lincoln The US FDA, a has finally published their QMSR to replace the previous QSR. Implementation deadline is February 02, 2026. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000 Clause 3) by reference.
• 

  
  Thu, 19 Feb

  Cybersecurity Expectations for GxP Systems / 

  Virtual Events

  Recording Available

  19 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Carolyn Troiano This course translates FDA cybersecurity expectations for GxP systems into clear, inspection-ready actions, bridging validation, data integrity, and modern IT realities.
• 

  
  Wed, 18 Feb

  Inspection Close-Out, Enforcement Risk, and Long-Term FDA Relationship Management / 

  Virtual Events

  Recording Available

  18 Feb 2026, 11:00 am – 1:00 pm GMT-5

  Virtual Events

  Faculty: Charles H. Paul This course teaches participants how to manage inspection close-out activities, FDA communications, and post-inspection commitments in a way that reduces enforcement risk and supports long-term regulatory credibility.
• 

  
  Wed, 18 Feb

  Human Error Investigation Program - Effective Implementation / 

  Virtual Events

  Recording Available

  18 Feb 2026, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Dr. Ginette Collazo Human error is a primary contributor to quality and production losses across various industries. While complete elimination of human error may be challenging, many performance problems can be effectively prevented.
• 

  
  Tue, 17 Feb

  Human Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes / 

  Virtual Events

  Recording Available

  17 Feb 2026, 11:00 am – 1:00 pm GMT-5

  Virtual Events

  Faculty: Charles H. Paul This course enables participants to understand how individual and team behavior influences FDA inspection outcomes, and how investigator interactions, verbal responses, and day-to-day conduct are evaluated as evidence of system control.
• 

  
  Fri, 13 Feb

  Successfully Investigating Deviations / 

  Virtual Events

  Recording Available

  13 Feb 2026, 11:00 am – 12:10 pm GMT-5

  Virtual Events

  Faculty: Danielle DeLucy This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
• 

  
  Wed, 11 Feb

  Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR / 

  Virtual Events

  Recording Available

  11 Feb 2026, 11:00 am – 12:15 pm GMT-5

  Virtual Events

  Faculty: David Nettleton This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.