Cleaning Validation: Best Practices

Cleaning Validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a company, a better understanding is needed. This 90-minute accredited training course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable, and informed decision making and activity planning. The course will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, cleaning SOPs, and other appropriate documentation. In addition, participants will understand the requirements for maintaining a validated cleaning process.