Quality is a perennial buzzword, both within the life sciences and in other industries. But how does a company go about determining exactly what sort of system is needed and making sure it is effective? In this audio conference our speakers provide insight into the use of quality systems to improve profitability in both FDA-regulated and non-regulated industries. The presentation looks at the key points to consider, starting with what is a quality system and how can it improve performance. The presentation also looks at the design and implementation of quality systems, and the return you can realistically expect to gain from putting a properly designed system in place.

This audio conference covers:

• What is a quality system?
• Designing and implementing a quality system
• Benefits of a properly designed quality system
• Using quality systems to improve profitability

About the speaker:

Ralph W. Donnelly is President of R. Donnelly & Associates, Inc., providing quality consulting services to FDA-regulated industries since 1990. Mr. Donnelly is involved in many engineering projects and uses a quality system approach to achieve success in the management of facilities, process improvements and validation. His consulting experience has given him broad experience with quality systems, and what makes some work while others do not. His clients include companies in various sectors -- pharmaceutical, biotechnology, nutraceutical, dietary supplement, medical device and process equipment. Mr. Donnelly has been a speaker and course leader at ISPE, PDA, IAT and International Quality and Productivity Center (IQPC). He has a BSME/IE from LeTourneau University and continued education through various professional organizations.

Frank Mark is President of the Polmarc Group and has over 30 years of experience in the pharmaceutical and medical device industries, with 7 years in the FDA and more than 20 years in the pharmaceutical industry. He has guided numerous companies in preparation for their first FDA pre-approval inspections, all of which were successful. He has directed several multi-site remediation projects across the US, Canada and Puerto Rico, and has provided quality oversight of commissioning and validation activities associated with new cGMP construction, installation and start-ups. He assists clients with all aspects of quality system implementation, remediation activities and regulatory compliance, from R&D to commercial manufacturing operations. Recently, Mr. Mark has worked with dietary supplement companies establishing quality systems tailored to meet 21CFR Part 111 requirements. He has a BS in Chemistry with graduate studies in Business Administration.

Who should attend?

• Senior Management
• VPs & Directors of Operations
• VPs & Directors of Quality
• Directors of Manufacturing

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.