August 25 @ 7:00 AM – 2:00 PM Virtual,United States
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Statistics and statistical methods are mentioned 14 times throughout FDA’s 19-page Process Validation Guidance. Although the concept was introduced in 2011, industry still struggles with using statistics effectively throughout the validation life cycle. KENX is proud to present this virtual training led by industry’s best statisticians and Subject Matter Experts. This is a seminar that teaches statistics to validation and quality professionals how to master validation statistics without being a statistician.
August 24 @ 7:00 AM – 4:00 PM Virtual,United States
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Although the concept was introduced in 2011, industry still struggles with the complex challenges of our rapidly change quality and technical environments. KENX is proud to present this virtual training that help you master a risk-based life cycle approach, good documentation practices, Continued Process Verification and much more that will have an immediate impact on your organization.
August 25 @ 12:00 PM – 4:45 PM
Virtual, United States
Effective change management is a critical component in your Quality System. A robust program should ensure procedures are justified, reviewed and approved by your quality unit. This seminar outlines the steps needed to build an effective program from the ground up. Top issues such as; implementing a risk-based approach, training personnel, identifying risks, monitoring effectiveness and creating checklists are discussed. Hear industry’s best SME’s from Sanofi Pasteur, Johnson & Johnson Vision Care and Azzur Training Group outline how to build, implement and maintain a best-in-class program.
https://kenx.org/wp-content/uploads/2020/07/virtual-training-3.jpg270780rculverhttps://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.pngrculver2020-07-30 01:18:582020-08-13 18:15:13CHANGE CONTROL & PROGRAM MANAGEMENT