Over the course of his career in the pharmaceutical and biotechnology industries, Mr. Guarracino has become a validation subject matter expert in a wide variety of disciplines. Mr. Guarracino has experience with Master Plans and CQV; process, computer, equipment and utility qualifications and consent decree remediation. Other experiences include regulatory strategies for filing MAA/BLA and submission filing for CBE-30.
Mr. Guarracino understands worldwide regulations, regulatory guidance documents and ICH guidelines. Mr. Guarracino is also very diverse with information technology hardware and software that is available within the industry.
Prior to joining ICQ Consultants, Mr. Guarracino worked as a Validation Consultant and was promoted to a Project Manager/Lead consultant for validation and qualification activities for AstraZeneca.