Best Practices for Laboratory Compliance

In the highly regulated Life Sciences Industry, complying with regulations is not an option, it's a necessity. When done correctly compliance programs can add value by improving system performance, increasing user productivity and ensuring data quality. Learn how to apply the right level of control in your regulated laboratory by using an effective risk based approach.

The discussion will include:

  • Ways to streamline effort associated with laboratory compliance
  • How to ensure compliance with regulatory requirements while reducing costs
  • How to stop considering compliance as overhead and instead increase business value through effective compliance programs
  • Live Q & A Session

About the Presenters:

Michael Ambrose 3

Michael Ambrose, Vice President of Laboratory Systems, USDM Life Sciences

Michael brings over 30 years of life science experience that includes 13 years in the pharmaceutical industry including roles managing a toxicology laboratory and clinical trials operations.  His industry experience was followed by 17 years providing consulting services to life science clients focusing on information technology compliance and risk management programs.

 

 

James Corwonski 85x105 left small file sizeJames Corwonski, Validation and Compliance Consultant, USDM Life Sciences 

James has his professional roots in industrial and pharmaceutical chemical labs.  As a computer geek before it was cool, he naturally embraced the automation surge of the late nineties and early two-thousands and evolved into a computer compliance specialist as the industry demanded.  In his 25+ years of industry experience and 15+ years of validation and compliance work, Jim has evolved right along with the industry standards--from ISO 9001 to 21CFR Part 11 to Annex 11--and has helped small, local companies as well as global organizations move from the all-inclusive compliance approach to a more practical, risk-based effort.

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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