Contains Web-based Seminars

Statistical Procedures Needed for Compliance with the Guidance on Process Validation - Webinar By GlobalCompliancePanel Overview: This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft. Thursday, September 6, 2012  more...

Document Retention and Destruction ...he more stringent requirement. If there is any area which contains documents under litigation, it is best to retain all records involved until the case is resolved and always refer to your company attorney for guidance. For your protection and convenience well-managed record-keeping not only aids in compliant administration, but gives you confidence in knowing you are prepared for any audit  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...quire regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address ways to conduct a security risk analysis to meet the requirements of HIPAA and the "meaningful use" rules. It will also provide examples of  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ... and device listing (the Proposed Rule).The Proposed Rule contains four types of proposed changes to FDA's device establishment registration and device listing regulations. For example, Proposed Rule would amend FDAa ™s current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory  more...