Biotech Web-based Seminars

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...lem is compounded by the confusion in the pharmaceutical, Biotech, and Medical device organizations as to what a Standard operating procedure is, and what a Work Instruction is. Areas Covered In the Session: * How to write a work instruction * How to write a standard operating procedure * Properties of an effective work instruction * Properties of an effective Standard  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ble help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ... can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation. Why should you attend: Process  more...