Understanding the Principles and Practices of Process Controls

Recently FDA has become increasingly concerned with the number of Warning Letters being issued due to problems with the control of manufacturing processes. Items listed in these various Warning Letters include lack of validation of manufacturing processes, lack of written procedures, improper sampling and testing of materials, and failure to follow written procedures. This course provides an understanding of what process control is. You will also learn about the written procedures involved in validation, how equipment affects process controls, batch production records, correct sampling and testing methods, proper reprocessing techniques, contamination control, change control, and process analytical technology.