Webinars
Event
- Title:
- Risk Based Validation of Laboratory Systems
- When:
- 02.09.2012
- Category:
- Laboratory Environments and Systems
Description
Webinar Date: February 9, 2012 Time: 11:00 to 11:30 PST
Summary:
Laboratory environments pose specific validation issues outside of the standard computer system validation issues. Calibration and maintenance of equipment, standalone systems, use of computer spreadsheets, security issues. Add to that, legacy systems and research and development activities and complexity just increases. This webinar discusses how to use risk management practices to streamline your lab systems validation efforts.
This webinar will address:
- How to develop a risk based validation program
- How to define low, medium and high risk systems
- Reducing testing through risk management
- Supplier risk assessment
- Documenting and justifying risk based decisions
Meet our Presenter:
Diane Gleinser is the Vice President of Operations for US Data Management. Ms. Gleinser has over 20 years of experience in Life Science based industries, encompassing Quality Assurance, Quality Control, Validation and Regulatory Compliance for research & development, clinical affairs, manufacturing and packaging, laboratory analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11. As a member of the senior management team at US Data Management, Ms. Gleinser leads a highly skilled team of implementation and compliance engineers, and has been instrumental in establishing USDMs Practice Groups. Ms. Gleinser is a member of International Society of Professional Engineers (ISPE), Regulatory Affairs Professional Society (RAPS), Parenteral Drug Association (PDA), and the Project Management Institute (PMI).
Sponsored By: USDM's Laboratory Practice Learn More
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About USDM
USDM is a leading global consulting firm focused on life sciences. We specialize in regulated business processes, with an emphasis on compliance and performance.
USDM provides innovative services and solutions that enable life science companies to achieve and maintain compliance across the entire enterprise.
