Our workshops will help you update your knowledge and skill in the latest Good Manufacturing Practices, quality assurance basics, validation and auditing.
Our instructors are carefully selected from industry to ensure you receive the most current material available.
This workshop is an introduction to process validation. Because process validation is a critical component of the FDA approval for pharmaceutical manufacturing, it is important to know the requirements, how to prepare your protocol, how to apply in-process testing, how to identify critical steps in the process and what are the acceptance criteria.
This is an introduction to equipment cleaning validation and how to reduce the work involved in validating the cleaning of every product. A matrix approach will be discussed to help participants in their approach to cleaning validation.
Documentation is an important element in GMP regulations. FDA and TPP approval of a pharmaceutical facility quality system. This seminar focuses on the requirements, retention and types of documents needed in pharmaceutical industries, SOPs and compliance/non compliance issues.
This workshop introduces the participants to various types of auditing such as API, third party for manufacturers, contract labs, warehouses and packaging facilities. It covers how to certify your supplier/vendor, how to set up an auditing program and how to prepare your auditing report.