Product Quality Lifecycle Implementation® (PQLI®) 101: Vision, Status and Next Steps ( WEBPQLI101 )
This training course provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10 and Q11. It covers development and manufacture of drug substances (chemical entities and biotechnological/biological entities) and the link between these and other relevant regulatory guidelines and the ISPE PQLI Guides.
Discuss the key concepts of the industry's history and vision
Describe the Vision, Purpose, and goals of PQLI
Identify potential benefits of PQLI
Discuss the Key Elements of the Product Realization Guides
Describe the importance of the Product Realization Guides