Clarus Validation Group Information

CVG is managed by two Principals with over 35 years combined experience working for pharmaceutical, biopharmaceutical, medical device and IVD companies. In addition, when project needs support it, the Principals at CVG can engage personnel from a network of qualified colleagues. We only engage sub-contractors and other consultants who have demonstrated to us, over a period of several years, that they possess the skills and experience required for a specific project or task. Selected highlights from staff experience include:Validation program development, improvement and remediationChange Control program development and managementLeadership, support and participation in regulatory inspections by FDA (CDER, CBER, CDRH, USDA), EMA, MHRA, EU Notified Bodies and othersRemediation projects within warning letter, notice of intent to revoke (NOIR) and consent decree environmentsProcess and Cleaning Validation for new product / process development and transferCleaning and sterilization process development and validationRoot cause analysis and process characterization and optimization using DoERisk Management (ICH Q9, ISO 14971)Equipment and facility design and specification approvals as representatives of the Quality and Validation functionsRegulatory compliance guidance and assessment for capital projects and existing operationsAudit and assessment of suppliers and CMO'sPete AndersonPete AndersonOwner/Principal ConsultantPeter Anderson is a validation professional with 17 years experience in the regulated Life Sciences industries. He has worked for large and mid-sized pharmaceutical, biotech and medical device manufacturers, developing and executing validation deliverables, presenting validation documents and strategies to global regulatory authorities in various settings (including pre-approval inspections for new products and new facilities) and developing, improving and managing validation programs. His experience encompasses all areas of validation applied to a wide array of product and manufacturing platforms, supporting all stages of the product and process lifecycle, from development, transfer and validation through continuous monitoring and improvement. He began Clarus Validation Group in 2013 to help industry build better validation programs, focusing on compliance, effectiveness, efficiency and sustainability.