regulatory compliance us Events

  • REACH RoHS Roundup: An End of Year Update on EU Regulatory Policy as it Applies to Product

    While the US presidential election and Brexit have loomed large in recent months, requirements concerning EU substance-related legislation have continued to progress. This webinar will review the latest developments including: Revisions to the RoHS Directive concerning scope, spare parts, exemptions, global standardisation and timings plus potential new substance restrictions under ...


    ONLINE

  • Webinar on How to conduct Annual Product Reviews to achieve GMP Compliance

    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. Areas Covered in the Session : Annual Product Review Overview How to write APRs What needs to be included in the report Outline the requirements for APR ...


    ONLINE

  • Webinar on US FDA 510(k) – Latest Guidance, Due Diligence, Preparation, Submission and Cle

    This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner, in accordance with lastest guidance. In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s ...


    ONLINE

  • Webinar on Process Capability Analysis using Confidence or Reliability Calculations

    The seminar begins with a discussion of relevant regulatory requirements, as motivation for calculating “confidence/reliability”. Then, some vocabulary and basic concepts are discussed. All the above is captured in these bullet points: Regulatory Requirements Vocabulary and Concepts Attribute Data Normal Data Normal Probability Plotting Non-Normal Data that can be ...


    ONLINE

  • Revised ISO14001 & the Product ‘Life Cycle’ Approach: the Small Change with Big Implicatio

    With the changes to the environmental systems management standard ISO14001, companies must now consider how the environment is affected by their products across their complete life cycle. Product regulatory compliance is key. This means that for many companies, the previously un-considered impact of the use and disposal of their products may now be their largest single environmental aspect. For ...


    ONLINE

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