Our January, 2009 meeting will be held on Tuesday, Jan. 27th at 6:00PM. Please RSVP to news@ssq.org.

Topic

Developing a Risk Based Approach to Validation

Bob Lucchesi, Global Practice Director, RCM Technologies, Inc.

The FDA and Pharmaceutical industry is now recommending guidelines on the validation of computer systems, software, and processes. Learn how to streamline validation costs while optimizing validation procedures.

Some topics will include:

• Developing a Risk Based Validation program for your company
• Categorizing risks and their respective plans
• Reducing Testing in a Risk Based Environment
• Developing a “how to” guide
• Developing documentation standards
• Differentiating tasks that will reduce time and effort
• Impacting strategies for maintenance
• Optimizing the Validation Plan

About Our Speaker

Bob Lucchesi is a seasoned professional possessing over 30 years of experience in various industries and technologies. He is considered a Subject Matter Expert in Life Sciences vertical, especially in validation, quality, content management, and computer systems. The past 19 years have been dedicated almost exclusively to Pharmaceutical and Medical Device consulting. Before this time, he was working in the IT technical arena, beginning with programming and advancing to data base administration and project management.

Mr. Lucchesi was also the President of a highly successful consulting firm in the nineties, specializing in Program Management, Process Improvement, and Infrastructure Assessments for the Pharmaceutical Industry. He is currently the Global Practice Director in the Life Sciences Division of RCM, supporting company staff worldwide in validation, quality, document management, data migration, and overall IT centric needs.

Some recent highlights include:

1. Authored a Risk Based Methodology for RCM
2. Performed a high level assessment for process improvement at a major Pharma
3. Coordinated a global migration of content for 3 top Life Sciences firms
4. Authored a White Paper on Program Management / Project Management for Life Sciences organizations
5. Spearheaded audits, research papers, and Six Sigma studies for several firms
6. Key advisor for Governance Standards at 2 of the top 10 Pharmaceutical companies

In addition, Mr. Lucchesi has spoken at several conferences and seminars on a variety of subjects centered on Life Sciences. He is well respected amongst his colleagues, and is considered a true leader in Pharmaceutical consulting. Having been exposed to all areas of Life Sciences (R&D, Clinical, Manufacturing, Sales and Marketing, Financial, Human Resources, Legal), Mr. Lucchesi brings extraordinary knowledge of Best Practices and Industry Standards.

Meeting Details

Date

Tuesday, January 27th, 2009 at 6:00PM

RSVP:

news@ssq.org

Cost (Including Dinner):

Members: $8.00
Students: $8:00
First-time guests: $8.00
Non-members: $15.00

Location:

Cardinal Health
(C1-A306)
6055 Lusk Blvd
San Diego CA 92121

From Lusk Blvd turn right at first driveway. Turn left at the roundabout. Drive around to the back of the building and park. The conference room is located at the rear of the bldg. and is accessible from the parking lot.

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