Upcoming Events

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  2 days to the event

  17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 3:00 pm GMT-5

  The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers / 

  Virtual Event

  Complete Information

  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
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  3 days to the event

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

  Using Audit Trails to Support Part 11 Data Integrity Compliance / 

  Virtual Event

  Complete Information

  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
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  4 days to the event

  19 Nov 2025, 7:00 pm – 11:00 pm

  Performance of Root Cause Analysis, CAPA, and Effectiveness Checks / 

  online

  Complete Information

  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
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  6 days to the event

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

  Reclassification of Software Automated Medical Devices / 

  Virtual Event

  Complete Information

  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
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  9 days to the event

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

  FDA Regulation for Over-the-Counter (OTC) Drug Products / 

  Virtual Event

  Complete Information

  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
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  10 days to the event

  25 Nov 2025, 11:00 am – 12:30 pm

  The Key Elements of Being “Recall-Ready”: What FDA Expects When Time Is Critical / 

  Virtual Event

  Complete Information

  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
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  19 days to the event

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

  How to write SOP’s for Human Error Reduction / 

  Virtual Event

  Complete Information

  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.
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  13 Nov 2025, 11:00 am GMT-5 – 14 Nov 2025, 3:00 pm GMT-5

  Writing SOP’s and Work Instructions that Really Work / 

  Virtual Event

  Complete Information

  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 .
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  12 Nov 2025, 11:00 am – 12:15 pm GMT-5

  Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance / 

  Virtual Event

  Complete Information

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

  Design Planning, Design History Files and Design Reviews / 

  Virtual Event

  Complete Information

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

  Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities / 

  Virtual Event

  Complete Information

  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.
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  05 Nov 2025, 11:00 am – 12:30 pm

  Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows / 

  Virtual Event

  Complete Information

  05 Nov 2025, 11:00 am – 12:30 pm

  Virtual Event