Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Areas Covered in the Session:E...

Training Options Duration: 60 Minutes Wednesday, November 8, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is...

Training Options Duration: 60 Minutes Wednesday, November 8, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have...

Overview: The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace. Why should you Attend:Understanding of the supply chain trends that will dramatically impact business over the 2-5 yearsWhy purchasing decisions must consider transparency and sustainability Why the triple bottom line is becoming increasingly important...

Training Options Duration: 60 Minutes Tuesday, November 7, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: This session will explain the HIPAA Rules for Web Sites and Social Media. The secret is - HIPAA Rules are easy to follow, step-by-step - when you know the steps. The HIPAA Rules, HHS/OCR guidance, Resolution Agreements provide a simple, easy to use blueprint using your Web Site and Social Media to engage patients and comply with HIPAA. Why s...

Overview:This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves". Why should you Attend:Whenever a test of statistical significance is conducted with the hope that the result will be non-significant, the results may be unacceptable to a regulatory agency unless the test had an acceptable level of "power". Ar...

Overview: Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods. Why should you Attend: Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances a...

Overview: It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. Why should you Attend:Are you spending too much of your own time trying to recover for the poor performance of team members? Are you missing deadlines because others can't get their work to you on time? Areas Covered in the Session:How to identify potential performance issuesHow to evaluate team...

Training Options Duration: 90 Minutes Friday, November 3, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: All researchers want their studies to be reviewed and approved quickly. The level of risk assigned a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed, need for additional protections, frequency of review, consent requirements, negotiation of indemnification language and several other...

Training Options Duration: 60 Minutes Friday, November 3, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Hospital acquired infection rates are of huge concern for patients, visitors, healthcare providers, and staff. The devastating repercussions of acquiring an HAI will not only affect the heath of those afflicted, but in the hospitals reputation as well. With allotted cleaning times reduced to fractions of an hour, the expectation of fully and...