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
• Project Managers
• Quality managers
• Quality Engineers
• Process Engineers
• Manufacturing Engineers.
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.