CVG is managed by two Principals with over 45 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
Peter Anderson is a validation professional with 22 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.
Malinda Kambs is a validation professional with more than 24 years of experience in the regulated Life Sciences industries. Her career has spanned various product and manufacturing platforms across those industries in a diverse range of manufacturing settings (including CMO). She has played key roles in successful remediation projects (including those involving Consent Decree and Notice of Intent to Revoke actions), and, for most of her career, in both management and non-management roles, has represented Validation Departments as a Validation Subject Matter Expert during regulatory and customer audits. In addition, Ms. Kambs has experience developing process, cleaning and analytical method validation and transfer programs for various drug platforms and industries as well as program design for, and implementation of, manufacturing process transfers from clinical scale to commercial manufacturing.