Change Control Web-based Seminars

GxP Computer System Validation The investigators Point of View - Webinar By GlobalCompliancePanel Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors. Tuesday, July 10, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Change Control Management From Design to Commercialization - Webinar By GlobalCompliancePanel There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/ systems specifications in addition to the more formal change control after the qualification of these systems. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...pecifications (URS) for analytical equipment o Change control for analytical equipment o Qualification of equipment o Allocating Analytical Instruments to USP Categories * Allocating Analytical Instruments to USP Categories Areas Covered in the Session: * Operational lab equipment requirements for calibration and qualification * Most common  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ffects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is required to resolve any underlying compliance issues or product problems that are  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ranted. 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 a renewed look at "grandfathered" product by the Agency is one result.  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...ally - to include regulatory requirements, design and/ or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? How to  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...investigation system will be integrated with the CAPA and Change Control Systems. Why you should attend: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel ...Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable  more...