This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
Why Should You Attend:
The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's inspectional observations. Their frequency lags only behind the quality unit concerns. Moreover, SOPs are often used as training tools, which means that they need to be easily understood by all those whom they affect. Effective SOPs are not only a regulatory requirement; they also make good business sense. Too many times employees fail to follow SOPs because they can't understand them, and too many times procedures are being constantly revised. This leads to lengthy and expensive investigations and costly revisions.
Who Will Benefit:
General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions
Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program for major pharmaceutical and biotechnology organizations.
Use coupon code NB5SQH8N and get 10% off on registration.