The 'why' and 'what' and the events / background that have impacted validation over the last 25 years will be presented.
The importance of an organization's Quality System for validation will be put into perspective to help attendees identify potential gaps in their validation programs. The presentation will discuss the importance of 'focusing on critical aspects' and having meaningful, well-written User Requirements Specifications as key elements on establishing a streamlined and simplified validation program for capital projects.
Why should you Attend:
Today's pharmaceutical manufacturing company's compliance with global regulatory expectations should not be a difficult task - but many companies are still finding it to be a challenge to get it right. FDA and EU regulatory expectations have evolved over the last 20 years and a new 'improved' validation approach is emerging that offers validation and engineering organizations the possibility of streamlining and simplifying validation activities.
This approach will help organizations control costs associated with building and starting new facilities and engineered systems. This may ultimately enable today's limited number of an organization's technical resources to spend their time and energy working on gaining better process knowledge as needed to optimize process capability.
Areas Covered in the Session:
Who Will Benefit: