Safety - Mechanical/Electrical

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?trainingregistry-April-2018-SEO

The NFPA 70E Standard for Electrical Safety in the Workplace has been updated for 2018. This updated standard contains significant changes when compared to the 2015 version. The course covers the requirements for working safely in the electrical environment based on the NFPA 70E. The webinar will discuss the core changes in the NFPA 70E 2018 standard and practical implementation of the changes. Special attention will be paid to the furthering of the philosophy of risk assessment and some lessons companies are learning to maintain the compliance with the standard and best practices. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/NFPA-70E-2018-Standard-for-Electrical-Safety-in-the-Workplace-Changes-From-2015-and-Practical-Implementation-507289/JANUARY-2018-ES-TRAININGREGISTRY

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016. This action is a milestone in consumer protection. Going forward, the FDA Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901294SEMINAR?trainingregistry-December-2017-SEO

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901324SEMINAR?trainingregistry-November-2017-SEO

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901112SEMINAR?trainingregistry-November-2017-SEO

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?trainingregistry-November-2017-SEO

Classification systems differ from that of the United States or European Union in select countries Medical devices are classified depending on their risk level Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. And Much More... Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900990SEMINAR?trainingregistry-November-2017-SEO