Detailed Web-based Seminars

Oracle Database 10g: Administration Level II One of the most challenging tasks ever presented to Oracle database administrators is that of recovery from failure, especially if the recovery must not result in a loss of any data. This Oracle trainig class presents all the standard failure scenarios and the best recovery strategies for each. Strategies for on-line backups, complete and incomplete recovery, media recovery vs.  more...

MOC 3938 - Updating Your Skills from Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 to Microsoft Exchange Serv This Microsoft Exchange training class targets Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 administrators who need to upgrade their skills to manage a Microsoft Exchange Server 2007 infrastructure. This class focuses on the new features and administrative tasks in Exchange Server 2007.Students will learn skills that enable them to deploy and manage an Exchange Server 2007  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...Short and quick overview of the Part 11 regulation * Detailed description of HOW TO prepare for an FDA inspection * When and Where Part 11 is in scope or the scope of the inspection; * Detailed description of HOW TO handle the FDA inspection during the inspection itself; * Some trends when it comes to Part 11 inspections; * Commonly asked questions; warning letters  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...ed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as preparation of the response to 483s will be discussed. Ample discussion time will be available at the halfway point in the webinar and again at the end of the webinar. Why you should attend: Pre-approval inspections provides  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...f the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be identified by a review of recent Warning Letters. The structure of an Investigation report which satisfactorily documents the  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...y of comparator drugs in some countries. * Decide on detailed timelines for study preparation, performance, and evaluation, including critical time points. * Start some initial feasibility into the countries of interest. * Ensure investigator brochure is available * Identify and decide on study management technologies and processes i. e. specific project management software  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...k) process and why manufacturers need to pay attention Detailed Agenda: Introduction and Regulatory Background * There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. * Current trends with the 510(k) process. The Process * Who is Required to Submit a 510(k) * When a 510(k) is Not Required * When a 510(k) is  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical  more...

Creating a Career Changing Personal Marketing Plan Workshop Series ... on past history; identifies problem areas and sets out a detailed plan to correct them; establishes objective goals with specific timelines; and creates a monitoring methodology. This 6 week series of tele-workshops moves from an understanding of what a real marketing plan does, completely through the creation of detailed, career changing, workable personal marketing plan. Potential  more...