This webinar is designed to to outline the characteristic of an effective work instruction,and Standard operating procedure.The webinar is also designed to help differentiate Work Instructions from Standard operating procedures.Attendees will learn the steps used to write effective work instructions and Standard operating procedures.
"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15
Why should you attend :
The current shift in FDA thinking is that manufactures do not give their employees enough direction to perform their jobs.This thinking is reflected in many warning letters that written to organizations by several FDA field offices.The problem 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:
1.How to write a work instruction
2.How to write a standard operating procedure
3.Properties of an effective work instruction
4.Properties of an effective Standard operating procedure
5.The differences between work instructions and Standard operating procedures.
Who will benefit:
Regulatory affairs professionals
Executive Managers faced with future FDA Inspections
About the speaker:
Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.