Filing Web-based Seminars

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...10(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ... o Where to find the information and forms for filing breach notifications with HHS. o What goes into an effective breach notification policy? o How to prevent breaches as much as reasonably possible. o What steps to take when a security incident or breach has occurred? o How to consider the risk of harm to the individual, and the risks of  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ... is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and ita ™s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U. S. and take  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...gulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences  more...

Office Organizing - Solutions Systems - On-Demand Webinar Office organizing can provide new or experienced Professional Organizers with a higher income stream than residential organizing can. However, if you are going to be an office organizer, you need to know how to do it well, or your reputation and your clients' businesses may suffer. Join Certified Professional Organizer ® Debra Milne as she talks about about the latest trends, resources and  more...

Excel at Filing - On-Demand Webinar ...Microsoft Excel ® can be used to create an electronic filing system including electronic filing practices; printing file inventory lists; searching and tracking files; networking an electronic filing system; setting passwords; navigating within an electronic filing system; and potential uses for an electronic filing system. Each of your clients will have to deal with paper ~ both at home  more...

Records Management 5 - Additional RM Program Components - On-Demand Webinar The last in the series of webinars dealing with Records and Information Management will look at the other program components that should be considered to develop an effective and efficient program. Topics covered include: vital records protection; choosing the right medium or mix of media for storing the records; scanning records; policies and procedures; privacy; placing records on hold for  more...

Records Management 3 - Retention Scheduling - On-Demand Webinar The third in the series of Records Management webinars covers retention schedules. Topics include what the schedule should include, how to gather the data, how to apply legislation and get approvals. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms  more...

Records Management 2 - Developing Classification Schemes that are Used - On-Demand Webinar This webinar describes what a classification scheme really is, what a corporate scheme should include, how to develop one to gain maximum buy-in and how to apply and maintain it to ensure continuing effectiveness. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and  more...

Records Management 4 - Records Management Software - On-Demand Webinar This webinar is the 4th in the series and it examines how the use of the proper software can greatly enhance the programa ™s effectiveness and reduce a lot of the more tedious, time consuming tasks associated with managing information. It will also cover the range of software options and how to develop and manage the process for developing system requirements and choosing the right solution.  more...

Records Management 1 - Its A Lot More Than Filing - On-Demand Webinar Records Management is a critical function in all businesses no matter what size the organization is. The larger the company the more complex records management becomes. In this first webinar of the Records Management series, learn the basics about this profession. Start to understand the terminology and the key components such as classification schemes, retention schedules, and the management  more...