QA/QC Focus: Validation/Mapping Studies

As more companies try to ensure that their validation activities are compliant and cost-effective, it has become increasingly important for quality professionals and validation technicians to manage costs and reduce downtime by accurately evaluating their validation equipment needs

 

As more companies try to ensure that their validation activities are compliant and cost-effective, it has become increasingly important for quality professionals and validation technicians to manage costs and reduce downtime by accurately evaluating their validation equipment needs. This is particularly the case in validation/mapping studies. Pharmaceutical Technology will hold a live webcast, “Optimizing Validation/Mapping Studies for GMP Compliance,”  on Wednesday April 10th at 11:00 AM EST to address this issue.

The 30-minute webcast will give participants a solid understanding of how to place sensors in thermal validation studies based on current regulatory guidance and scientific principles by providing a tutorial on how to determine the number and placement of sensors during validation/mapping studies. The webcast will discuss environments of all sizes: tabletop incubators, small refrigerators, cold rooms, and warehouses.

The panelists include Charles Lankford, CEO and co-founder of the life-sciences consulting firm PharmaSys, Inc., where he provides strategic direction for the company and acts as a senior auditor/consultant. He has served as validation project manager for a multitude of projects and has performed numerous compliance audits of laboratories, clinical research organizations, and manufacturing facilities. He is recognized as an authority in the fields of validation, FDA regulations, BE/BA studies, and quality assurance with more than 30 years of experience, which has included assignments with Johnson & Johnson, Burroughs Wellcome and Glaxo Wellcome (now GlaxoSmithKline).

Also speaking will be Paul Daniel, senior regulatory compliance expert, Vaisala, who has more than 15 years of validation experience in the pharmaceutical and medical-device industries. He has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network and computer validation. He has an extensive practical grounding in applying the GMP principles found in 21 CFR Parts 11, 210, 211, and 820. His specialties include: authoring and executing validation protocols (IQ and OQ) for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines.

Registration and additional information for the webcast may be found here.