IRB and Other Committees for Smooth Clinical Trial Conducts Clinical InformaticsThis webinar will introduce the participants to some of the committees that are involved or are necessary for the conduct of clinical trials. The IRB process will normally decide if the trial Read more
Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it. Clinical InformaticsThis system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement Read more
10 Tips for Submitting Human Subjects Protocols Clinical InformaticsInstitutional Review Boards (IRB) also known as ethics committees or ethical review boards were established by federal regulation in 1974. IRBs are independent committees designated to approve, mon Read more
Federal wide Assurances: What are they; why and when do I need them? Clinical InformaticsThe Federal Wide Assurance requires written agreements with non-affiliated investigators. These agreements are assurances under which a research study will be conducted. The Federal wide As Read more
New Part 11 Guidance for Clinical Trials: What This Means for You Clinical InformaticsFDA regulations related to Good Clinical Practices includes Electronic Medical Records and Electronic Signatures. Governing those is 21 CFR Part II. The Department of Health and Human Service equiv Read more
What is a Serious Adverse Events and how do I handle these? Clinical InformaticsSerious adverse events along with their cousins, serious adverse reactions, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. Read more
Trial Master File (TMF): FDA Expectations from Sponsors and Sites. Clinical InformaticsCompanies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be store Read more
Deviations: What are they? Do you need to report? Clinical InformaticsDeviations have often been misunderstood, misclassified, and misreported. Adding to the confusion is terminology that has been applied to deviations, leaving the study team, the study monitors, and Read more
Safety Issues Associated with Electronic Health Records Integration Clinical InformaticsAs a result of the American Reinvestment & Recovery Act in 2009, the integration of the electronic health record system (EHR) revolutionized the documentation of patient care. The expectations Read more
Writing Ethical, Focused and Credible Internal Audit Reports
Speaker: Philip VassalloPrice: $285
Moving from an Operational Manager to a Strategic Leader
Speaker: Chris DeVanyTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Logistics Channel Incoterms Standards
Speaker: Dr. Rossano V. GeraldTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.