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 remediation Change Control program development and management Leadership, support and participation in regulatory inspections by FDA (CDER, CBER, CDRH, USDA), EMA, MHRA, EU Notified Bodies and others Remediation projects within warning letter, notice of intent to revoke (NOIR) and consent decree environments Process and Cleaning Validation for new product / process development and transfer Cleaning and sterilization process development and validation Root cause analysis and process characterization and optimization using DoE Risk Management (ICH Q9, ISO 14971) Equipment and facility design and specification approvals as representatives of the Quality and Validation functions Regulatory compliance guidance and assessment for capital projects and existing operations Audit and assessment of suppliers and CMO's Pete Anderson Pete AndersonOwner/Principal Consultant Peter 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 ...