Upcoming Events

• 

  
  4 days to the event

  Tue, 02 Dec

  Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out / 

  Virtual Events

  Complete Information

  02 Dec 2025, 11:00 am – 2:00 pm GMT-5

  Virtual Events

  Faculty: Michael Esposito Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency.
• 

  
  5 days to the event

  Wed, 03 Dec

  CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See / 

  Virtual Events

  Complete Information

  03 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Carolyn Troiano Modern life-sciences teams are under increasing pressure to deliver systems that work, withstand scrutiny, and don’t drown projects in unnecessary documentation.
• 

  
  6 days to the event

  Thu, 04 Dec

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

  Virtual Events

  Complete Information

  04 Dec 2025, 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.
• 

  
  6 days to the event

  Thu, 04 Dec

  How to write SOP’s for Human Error Reduction / 

  Virtual Events

  Complete Information

  04 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Dr. Ginette Collazo Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. Procedures are essential for both execution and audits.
• 

  
  10 days to the event

  Mon, 08 Dec

  FDA’s 21 CFR Part 11 Add-on Inspections / 

  Virtual Events

  Complete Information

  08 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: John E. Lincoln Medical devices software have become integral and indispensable in the controlling, running and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics or dietary supplements industries
• 

  
  11 days to the event

  Tue, 09 Dec

  Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements / 

  Virtual Events

  Complete Information

  09 Dec 2025, 11:00 am – 12:00 pm GMT-5

  Virtual Events

  Faculty: Charles H. Paul Data integrity is a fundamental requirement in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the reliability, accuracy, and security of data throughout the product lifecycle.
• 

  
  12 days to the event

  Wed, 10 Dec

  The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 / 

  Virtual Events

  Complete Information

  10 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: John E. Lincoln The US FDA, after years of discussing the harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485, Device QUS, has finally moved closer to implementation.
• 

  
  13 days to the event

  Thu, 11 Dec

  ChatGPT and AI-Powered Project Management - Revolutionize your Projects Now / 

  Virtual Events

  Complete Information

  11 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Charles Paul Artificial Intelligence (AI) is revolutionizing project management, transforming how projects are planned, executed, and monitored.
• 

  
  14 days to the event

  Fri, 12 Dec

  Quality Metrics & KPIs: How to Measure What the FDA Actually Cares About / 

  Virtual Event

  Complete Information

  12 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Event

  Faculty: Meredith Crabtree This 90-minute training, titled "Latest Regulations in Quality Metrics and KPIs," offers a comprehensive exploration of the evolving landscape of quality metrics and key performance indicators (KPIs) across various regulated industries.
• 

  
  17 days to the event

  Mon, 15 Dec

  The FDA Inspection from SOP to 483 / 

  Virtual Events

  Complete Information

  15 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: José Mora This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
• 

  
  17 days to the event

  Mon, 15 Dec

  IQ, OQ, PQ in the Verification and Validation Process / 

  Virtual Events

  Complete Information

  15 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: John E. Lincoln‎ This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
• 

  
  18 days to the event

  Tue, 16 Dec

  Project Management Best Practices for Computer Systems Regulated by FDA / 

  Virtual Events

  Complete Information

  16 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Carolyn Troiano We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment.
• 

  
  18 days to the event

  Tue, 16 Dec

  How to conduct Annual Product Reviews to achieve GMP Compliance / 

  Virtual Events

  Complete Information

  16 Dec 2025, 11:00 am – 12:15 pm GMT-5

  Virtual Events

  Faculty: Danielle DeLucy This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
• 

  
  18 days to the event

  Tue, 16 Dec

  Project Management Best Practices for Computer Systems Regulated by FDA / 

  Virtual Events

  Complete Information

  16 Dec 2025, 11:00 am – 12:30 pm GMT-5

  Virtual Events

  Faculty: Carolyn Troiano We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle.
• 

  
  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.