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:
25 Years of Validation
Commissioning and Qualification (De-mystified)
EU vs US GMP (Regulatory Expectations)
The Importance of ASTM E2500
KISS Examples: Keep It Streamlined and Simple
Reasons for Poor Validation Programs
Q & A
Who Will Benefit:
Managers / Directors of Validation
Managers / Directors of Engineering
Managers / Directors of Quality Assurance
Sr. Validation Engineers and Project Managers
Regulatory Compliance Professionals
Sam DeMarco is a Sr. Compliance Consultant and president of Compliance Team, Inc. Sam has over 25 years of technical, managerial, and consultative experience in the pharmaceutical and medical device industries. He earned his MBA from Loyola University of Chicago and BS in Mechanical Engineering from the University of Illinois. In 2009, he earned the International Society of Engineer’s certified pharmaceutical industry professional (CPIP) credential. His subject matter expertise covers a broad area of knowledge, which includes engineering, commissioning, validation, project management, quality assurance, and pharmaceutical manufacturing and product quality compliance. Sam’s comprehensive knowledge of and experience with implementing technical requirements for a diverse portfolio of projects has helped him to be an accomplished expert on developing robust quality system policies and procedures. His leadership has contributed too many successful launches of new manufacturing facilities, process technologies, and products in compliance with regulatory requirements and expectations.