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Fitness

Upcoming Webinars

  • The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers
    The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers
    2 days to the event
    17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 3:00 pm GMT-5
    Virtual Events
    17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 3:00 pm GMT-5
    Virtual Events
    Faculty: John E. Lincoln | November 17 - 18, 2025 | Time: 10 AM to 3 PM Global companies must meet US FDA 21 CFR 820 (The QSR) requirements in order to sell such devices in the US, no matter where they are manufactured.
  • Developing Effective Post Market Surveillance and Complaint Handling Requirements
    Developing Effective Post Market Surveillance and Complaint Handling Requirements
    2 days to the event
    17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 4:00 pm GMT-5
    Virtual Events
    17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 4:00 pm GMT-5
    Virtual Events
    Faculty: JOHN E. LINCOLN | November 17 - 18, 2025 | Time: 10 AM to 4 PM This seminar will provide valuable assistance to all regulated companies that need a repeatable methodology / defined systems, and simple but powerful tools for "closed loop" CAPA
  • Using Audit Trails to Support Part 11 Data Integrity Compliance
    Using Audit Trails to Support Part 11 Data Integrity Compliance
    3 days to the event
    18 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    18 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: Carolyn Troiano | Date: Nov 18 | Time: 11:00 AM - 12:30 PM We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and data integrity, and the importance of managing electronic records.
  • Reclassification of Software Automated Medical Devices
    Reclassification of Software Automated Medical Devices
    6 days to the event
    21 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    21 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Friday, November 21, 2025|Faculty: José Mora Software-automated medical devices are transforming healthcare by leveraging advanced algorithms to perform critical tasks traditionally handled by medical professionals.
  • FDA Regulation for Over-the-Counter (OTC) Drug Products
    FDA Regulation for Over-the-Counter (OTC) Drug Products
    9 days to the event
    24 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    24 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: Meredith Crabtree ‎|‎ ‎‎Date: 11/24/2025 11:00 AM - 11/24/2025 12:30 PM Time zone: Eastern Time (US/Canada) This training offers numerous benefits for professionals involved in the development, manufacturing, regulatory affairs, and marketing of Over-the-Counter (OTC) drugs.
  • The Key Elements of Being “Recall-Ready”: What FDA Expects When Time Is Critical
    The Key Elements of Being “Recall-Ready”: What FDA Expects When Time Is Critical
    10 days to the event
    25 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    25 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: Meredith Crabtree Date: Nov 25 11:00 AM - 12:30 PM Recent FDA guidance makes clear what the agency expects: swift initiation, clear communications, and documented processes. Being “recall-ready” means your facility has the systems, training, and protocols in place before problems arise — no
  • How to write SOP’s for Human Error Reduction
    How to write SOP’s for Human Error Reduction
    19 days to the event
    04 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    04 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    Faculty: Dr. Ginette Collazo | Date: 12/04/2025 11:00 - 12:30 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.
  • Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR
    Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR
    19 days to the event
    04 Dec 2025, 11:00 am – 12:15 pm GMT-5
    Virtual Events
    04 Dec 2025, 11:00 am – 12:15 pm GMT-5
    Virtual Events
    Faculty: David Nettleton | Date: 12/04/2025 | Time:11:00 - 12:15 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.
  • Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements
    Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements
    24 days to the event
    09 Dec 2025, 11:00 am – 12:00 pm GMT-5
    Virtual Events
    09 Dec 2025, 11:00 am – 12:00 pm GMT-5
    Virtual Events
    Faculty: Charles H. Paul | Date: 12/09/2025 11:00 - 12:00 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.
  • The US FDA QMSR Transition - 21 CFR 820 and ISO 13485
    The US FDA QMSR Transition - 21 CFR 820 and ISO 13485
    25 days to the event
    10 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    10 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    Faculty: John E. Lincoln | Date: 12/10/2025 11:00 - 12:30 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.
  • The FDA Inspection from SOP to 483
    The FDA Inspection from SOP to 483
    30 days to the event
    15 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    15 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    Faculty: José Mora | Date: 12/15/2025 | Time:11:00 - 12:30 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.
  • Project Management Best Practices for Computer Systems Regulated by FDA
    Project Management Best Practices for Computer Systems Regulated by FDA
    31 days to the event
    16 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    16 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Events
    Faculty: Carolyn Troiano | Date: 12/16/2025 | Time: 11:00 - 12:30 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.
  • How to conduct Annual Product Reviews to achieve GMP Compliance
    How to conduct Annual Product Reviews to achieve GMP Compliance
    31 days to the event
    16 Dec 2025, 11:00 am – 12:15 pm GMT-5
    Virtual Events
    16 Dec 2025, 11:00 am – 12:15 pm GMT-5
    Virtual Events
    Faculty: Danielle DeLucy ‎| Date: 12/16/2025 | Time: 11:00 -12:15 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.

Past Webinars

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