A Case Study in Commissioning and Validation Application of Commissioning and Validation to a cGMP Project

Conducted by Lou Angelucci - Vice President, Inverness Medical Innovations

May 22, 2008

Commissioning of systems and equipment within the pharmaceutical industry in the USA has become an industry standard. While the intent of the practice was to streamline as well as cut the cost associated with qualification process, it has also become entangled in the documented evidence web of cGMP compliance.

Every system and piece of equipment utilized in the pharmaceutical and medical device industries is subject to a commissioning exercise. Commissioning using a  well documented approach is best applied to new equipment and system installations.

Commissioning along with qualification is now being viewed as routine aspects of the overall qualification process. It is imperative that these steps be performed in a structured, analytical and compliant way. Current FDA regulations do not mandate that commissioning or Impact assessments be performed, but it is definitely the trend in the industry today.

Topics and issues associated with the application of Impact Assessment and Commissioning to be discussed include:

• What thinking and planning were involved
• Where the concept of Impact assessment started
• How Impact Assessments impacted the project
• Documentation flow
• How the application of the concepts affected the final outcome of qualification and validation
• Lessons learned
• Things to do next time

This seminar will address these issues and demonstrate how in this application, these points impacted this validation effort. This seminar will be conducted on the telephone and is presented by Lou Angelucci, an industry expert on the topic of commissioning, qualification and validation.

In this unique audio seminar format, lasting just one hour, Mr. Angelucci will draw from this real life situation to share this and his extensive experience in streamlining the validation process. He will discuss the critical highlights of Commissioning and Validation as well as the pitfalls that can be avoided.

You will be able to follow along with a PowerPoint presentation, ask questions and interact with Mr. Angelucci during the audio seminar. An outline of this seminar and Lou Angelucci’s qualifications can be found below.

A Case Study in Commissioning and Validation

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Can't attend? Get the CD and handout GMP074252E - CD and Handout materials A Case Study in Commissioning and Validation CD price includes HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar

$397.00

Instructor

Lou Angelucci - Vice President, Inverness Medical Innovations
Lou Angelucci is responsible for pharmaceutical manufacturing and ensuring quality and compliance to cGMPs for facilities, equipment, utilities, computer and process control systems. Lou works in close collaboration with the Qualification/Validation Operations group, and with the Facilities/Engineering and Computer Systems organizations.

Lou has over 20 years of experience in various aspects of validation and cGMP compliance. He has many years of blood product experience having started his career with Extracorporeal, a Johnson & Johnson company. Here he was active in the qualification and transfer of products from development to manufacturing. He has traveled extensively overseas to conduct cGMP audits and provide guidance on engineering, design, equipment and process issues. Lou has extensive experience in cGMP, EU, CSV and CFR Part 11 compliance. He also has extensive experience in commissioning issues, API, Biotech and sterile process validation and Validation Master Planning. Lou is a frequent lecturer to various industry associations on the topics of cGMP compliance and validation. He also has authored numerous articles on these subjects, serves on the Board of Directors for the Journal of Validation Technology and is an active member of the ISPE. Lou has a BS degree in Biology, an M.S.E degree in Biomedical Engineering and M.S.E. degree in Engineering Management.

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