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Upcoming Events

  • 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
    3 days to the event
    Mon, 17 Nov
    Virtual Event
    17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 3:00 pm GMT-5
    Virtual Event
    Faculty: John E. Lincoln | November 17 - 18, 2025 US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM
  • Using Audit Trails to Support Part 11 Data Integrity Compliance
    Using Audit Trails to Support Part 11 Data Integrity Compliance
    4 days to the event
    Tue, 18 Nov
    Virtual Event
    18 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: Carolyn Troiano Date: Nov 18 11:00 AM - 12:30 PM In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process
  • Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
    Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
    5 days to the event
    Wed, 19 Nov
    online
    19 Nov 2025, 7:00 pm – 11:00 pm
    online
    This expanded training course provides a deep dive into Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Checks in FDA-regulated industries. Participants will gain hands-on experience with industry-leading RCA tools such as 5 Whys, Fishbone Diagrams, Pareto Anal
  • Reclassification of Software Automated Medical Devices
    Reclassification of Software Automated Medical Devices
    7 days to the event
    Fri, 21 Nov
    Virtual Event
    21 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: José Mora Software-automated medical devices are transforming healthcare by leveraging advanced algorithms to perform critical tasks traditionally handled by medical professionals. From automated insulin delivery systems to AI-powered diagnostic tools and robotic surgical assistants, these
  • FDA Regulation for Over-the-Counter (OTC) Drug Products
    FDA Regulation for Over-the-Counter (OTC) Drug Products
    10 days to the event
    Mon, 24 Nov
    Virtual Event
    24 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Faculty: Meredith Crabtree ‎|‎ ‎‎ Code: FDB3614 The webinar will explore the differences between OTC Monograph submissions and New Drug Applications (NDA), as well as the timeline and requirements for OTC drug approval
  • 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
    11 days to the event
    Tue, 25 Nov
    Virtual Event
    25 Nov 2025, 11:00 am – 12:30 pm
    Virtual Event
    Faculty: Meredith Crabtree Date: Nov 25 11:00 AM - 12:30 PM his course will give you practical clarity on FDA expectations, what processes your organization must establish, and how to respond correctly when a recall notice arrives. You will leave prepared to protect your company, your customers, and
  • How to write SOP’s for Human Error Reduction
    How to write SOP’s for Human Error Reduction
    20 days to the event
    Thu, 04 Dec
    Virtual Event
    04 Dec 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    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.
  • Writing SOP’s and Work Instructions that Really Work
    Writing SOP’s and Work Instructions that Really Work
    Thu, 13 Nov
    Virtual Event
    13 Nov 2025, 11:00 am GMT-5 – 14 Nov 2025, 3:00 pm GMT-5
    Virtual Event
    November 13 - 14, 2025 | 11 AM to 3 PM | Faculty: CHARLES H. PAUL This seminar delves into the nuances of creating effective Standard Operating Procedures (SOPs) and Work Instructions that enhance business operations .
  • Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance
    Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance
    Wed, 12 Nov
    Virtual Event
    12 Nov 2025, 11:00 am – 12:15 pm GMT-5
    Virtual Event
    Faculty: David Nettleton Date: Nov 12 11:00 AM - 12:15 PM This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions
  • Design Planning, Design History Files and Design Reviews
    Design Planning, Design History Files and Design Reviews
    Wed, 12 Nov
    Virtual Event
    12 Nov 2025, 11:00 am – 12:00 pm GMT-5
    Virtual Event
    Faculty: Alan M. Golden‎ ‎|‎ ‎ ‎‎Code: MD3596 Date:11/12/2025 11:00 - 11/12/2025 12:00 Location Online Event
  • Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
    Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
    Thu, 06 Nov
    Virtual Event
    06 Nov 2025, 11:00 am – 12:30 pm GMT-5
    Virtual Event
    Drug Master Files (DMFs) play a pivotal role in the pharmaceutical industry as confidential documents containing detailed information about the manufacturing, processing, packaging, and storage of active pharmaceutical ingredients (APIs), excipients, and other essential components of drug products.
  • Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows
    Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows
    Wed, 05 Nov
    Virtual Event
    05 Nov 2025, 11:00 am – 12:30 pm
    Virtual Event
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