Pharmaceutical Validation (PHAR490)
This course is designed to provide a basic understanding of pharmaceutical validation through discussion and case studies based on regulatory expectations such as FDA (US Food and Drug Administration) and EMA (European Medicines Agency). Various approaches to validation will be discussed with actual examples of successes and failures from the industry experiences. It will give the attendee an overview and understanding of the validation processes such as equipment and facility qualifications, process validation, cleaning and analytical method validations applied in the pharmaceutical industry.