Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations...

This program is the second in a series entitled, "Doing Business with the Department of Defense." So far in FY2016 according to USA Spending.gov, the three branches of service, Navy, Army and Air Force have awarded over $37 Billion in new contracts through 100,000+ transactions. Each branch currently has awarded over $11 Billion individually. These account for about 25% of all transactions from DoD agencies so far. These three branches are the...

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Paul Hales, with a team of expert advisors and practical field testers, have created a method of making all HIPAA regulations accessible to the everyday person, explained in plain language with exact citations to each regulation for the benefit of the organizations' legal counsel who may not be experienced in HIP...

Overview: Most entities actively seek maximizing stakeholder return on investments and fostering superior customer relations to sustain creation justification. With information technologies considered indispensable to providing processing efficiency, communication expediency and information reliability for stakeholders; entities need to safeguard adequately information assets because they have measurable value. Management typically requires a...

Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments. Because regulations are legally binding requirements based upon statutory laws and judicial opinions, it is essential that professionals in the pha...

Overview: The ISO 14071 standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also spe...

Overview: The clinical research community continues to struggle with privacy protections and the subsequent limitations on direct access to electronic health records (EHR) for monitors, auditors and even regulatory authorities. Since these EHRs house the original source data supporting regulatory approvals, some level of source document verification is expected. We'll discuss the risks and benefits of a number of 'alternative' methods being us...

We’re thrilled that you’ve chosen our conference to renew your passion, infuse your practice, grow as a professional, and find inspiration to lead your team in remarkable new ways in the year ahead. With more than 200 sessions, 5 general sessions, and multiple opportunities to network with colleagues and experts, there’s no better time or place to take charge of your career. Read on for the latest news and important info to h...

Back by popular demand...and with the details of the latest news! The FAR Council has issued the rule that thousands of Federal Contracting Officers have been waiting for. Effective immediately, they can begin to award sole-source contracts under the WOSB program. But did you know? Less than 3% of federal contract dollars are awarded as sole source through ANY of the small business programs. Find out how your WOSB can join the elite group of s...

The International Conference on Nanotechnology and Environmental Issues (ICNEI'16) aims to become the leading annual conference in fields related to nanotechnology and environmental issues. The goal of ICNEI'16 is to gather scholars from all over the world to present advances in the relevant fields and to foster an environment conducive to exchanging ideas and information. This conference will also provide an ideal environment to develop new c...