Assuring Web-based Seminars

Preventing Harassment in the Workplace by TrainHR ...t should be communicated, and who is held responsible for assuring compliance. Also included is handling complaints, documenting charges and conduct and addressing any situation that may be construed as harassment. It will also describe liability for the company and/ or its supervisors. It will discuss the rights of the employee and how important it is to have a no retaliation policy to protect  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...n-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to  more...

Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...