March 2007 Series of Pharmaceutical & Biotech Live Web Seminars and Discussion Groups
Technological changes and growth of competition in the healthcare industry are remodeling the business strategies of leading pharmaceutical and biotech companies. At BenAstrum, we understand that healthcare companies are continuously looking for innovative ways to decrease costs, increase productivity and enhance profitability. BenAstrum has brought together an elite assembly of senior pharmaceutical consultants to deliver the fundamental knowledge that companies require to meet those objectives. BenAstrum will host over 100 webinars on various topics in 2007, delivering the most essential knowledge your company requires to expand in today’s competitive industry.
Agenda:
Monday, March 26, 2007
Session A:
“A Look at Quality and Compliance”
Time: 8:30 a.m. – 12:00 p.m. EST
Speaker: Dr. Frank S. Kohn; President, FSK Associates
During the first session of this knowledge-based Web Seminar, Dr. Frank S Kohn (former Director of Wyeth Vaccines) will discuss the various issues and trends related to environmental monitoring, and the methods that a company can utilize to optimize recording of data.
The second session will focus on FDA Audits, outlining the responsibilities of Quality Control personnel in complying with industry regulations.
Topics:
1- “A Quality System Approach to Environmental Monitoring”
2- “An Auditor’s View of FDA Requirements for QC Laboratory Compliance”
Tuesday, March 27, 2007
Session B:
“An Expert’s Overview of the FDA Guidance Document & How to Prepare for an FDA Inspection”
Time: 9:00 a.m. – 12:00 p.m. EST
Speaker: Jeanne Moldenhauer, PhD; Vectech Pharmaceutical Consultants Inc.
Over the past several years, the FDA has implemented a “Systems Based Inspection Guidance” for Drugs, substantially changing the way inspections are performed.
Topics:
•Overview of the new FDA “ System Based Inspection Guidance” for drugs
•The novel procedures of FDA inspections
•Various steps to be implemented by companies in preparation for such FDA inspections
Session C:
“An Expert’s Guidance for Microbial Environmental Monitoring & Environmental Control for Aseptic Processing Facilities”
Time: 1:00 p.m. – 4:30 p.m. EST
Speaker: Margarita Gomez, PhD; VPCI Inc.
Topics:
1- “Comprehensive Environmental Control Program for Aseptic Processing Facilities”
2- “Microbial Environmental Monitoring Program”
Wednesday, March 28, 2007
Session D:
“An Expert’s View of Cleaning Validation, Media Fills Standard Procedures & Related FDA Regulations”
Time: 1:00 p.m. – 4:30 p.m. EST
Speaker: Dr. Frank S. Kohn; President, FSK Associates
Topics:
1- “Cleaning Validation & 483s”
2- “Media Fills – Success or Failure?” (A Review of Industry Practices)
Thursday, March 29, 2007
Session E:
“An Expert’s Guidance for Microbial Environmental Monitoring & Environmental Control for Aseptic Processing Facilities”
Time: 8:30 a.m. – 12:00 p.m. EST
Speaker: Dr. Margarita Gomez; VPCI Inc.
Topics:
1- “Comprehensive Environmental Control Program for Aseptic Processing Facilities”
2- “Microbial Environmental Monitoring Program”
Benefits Include:
•Learn from prominent speakers during live sessions, within the comfort of your own office
•Gain breakthrough insights from senior pharmaceutical consultants
•Explore best practices from top companies
•Learn about the latest products and technologies in the pharmaceutical industry
•Interactive and hands-on workshops providing in-depth learning opportunities
•Enjoy extended online networking
•& much more
Take your first step with us towards obtaining real time information. We look forward to receiving your questions, comments and suggestions.
Please visit www.benastrum.com for indepth information and registration.
Registration Office:
Michael Riva
Event Coordinator
Local: (514) 337-1616
Fax: (514) 337-8803
Email: Michael.Riva@BenAstrum.com