online training Events

  • Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)

    Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, ...


    ONLINE

  • Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

    A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are included. All component functions are detailed with recommendations as to which component type is considered optimal. The four contamination sources in compressed air are discussed. These are: a) solid particulate b) water content c) total oil content d) ...


    ONLINE

  • FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

    This webinar will look at changes in FDA’s approach to audits and the current method used to determine audit frequencies by using a system of risk assessments. Within the industries of pharma, biotechnology and medical devices, the word ‘audit’ can cause anxiety when you are unaware of how your company’s practices and procedures compare to the rest of the industry. Part of successfully getting ...


    ONLINE

  • FDA’s Two New Draft Guidance on Software and Device Changes and the 510(k)

    This session help you implement formal methods with documented and defensible rationale—which will prepare your organization for further 510(k) changes in the future, especially if your company is in the Medical Device and combination products fields. This is a long awaited clarification of U.S. FDA’s Memo K97-1 for medical device manufacturers, with far-reaching effects in regulatory compliance ...


    ONLINE

  • FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices

    This webinar presents important facts to simplify the planning and execution to ensure that the findings by FDA as 483s or as the more serious warning letters are addressed appropriately so your quality system is always audit proof and ready for the QSIT Inspectors. After having successfully emerged out of a FDA 483 or a warning letter for your medical devices, it is a challenge to maintain the ...


    ONLINE

  • Offshore Technology Conference

    The Offshore Technology Conference (OTC) is where energy professionals meet to exchange ideas and opinions to advance scientific and technical knowledge for offshore resources and environmental matters. OTC is the largest event in the world for the oil and gas industry featuring more than 2,400 exhibitors, and attendees representing 120 countries. Founded in 1969, OTC’s flagship conference ...


    HOUSTON

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

    In this webinar, our presenter John Lincoln, will address the use of the FDA guidance documents, GAMP, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. This session will also discuss and explain about a compliant, field tested (FDA and Notified Body) 21 CFR Part 11 software ...


    ONLINE

  • Infometrix General Chemometrics Training Course

    This three-day session specializes in hands on training in chemometrics. The course covers topics such as data collection for multivariate analysis, model optimization and model building, classification, regression and data exploration techniques. Methods and tools for on-line, process, routine and automated chemometrics are also introduced to the attendee. Hands on experience and demonstrations ...


    BOTHELL

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