online training Events

  • 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 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 How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program

    FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what ...


    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

  • Webinar On Are you ready for the next FDA inspection? – Inspection Readiness Preparation

    Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist? Who should security/receptionist call when FDA arrives unannounced at your firm? That’s right, FDA does not schedule an inspection – they just show up, present their credentials and ...


    ONLINE

  • Webinar on Effective Standard Operating Procedure (SOPs) Development for Regulatory Compli

    You will learn and understand about written procedures, and why they are beneficial. Our speaker will also cover important subjects such as FDA expectations for written documents and regulatory requirements, implementation of a training program for creating and reviewing documents, development of a system for controlling, archiving and disposing of written proposals, and development of an ...


    ONLINE

  • Food Processing Expo 2017

    With more than 260 exhibitors and 2600 attendees, Food Processing Expo is the largest tradeshow in California devoted exclusively to food processing.  The purpose of the Expo is to bring the industry together by offering a tradeshow floor with exhibits featuring machinery, equipment, supplies, services and other vendors with innovative products for the industry. In addition to the exhibits, ...


    SACRAMENTO

  • IAIA17 - 37th Annual Conference of the International Association for Impact Assessment

    Climate change represents a key challenge to the sustainability of global ecosystems and human prosperity in the 21st century.  Climate change goes beyond project impacts, as it affects many diverse global issues:  from water, food, and energy security to impacts on human rights and vulnerable peoples. Global climate change raises important questions of international and ...


    MONTRÉAL

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