Tina Sammarco Email & Phone Number

Florida, United States

Laboratory, Quality Systems, and Manufacturing Compliance Auditor for the FDA/MHRA industries. Project Construcition and Validation Manager Facility Builds.

Medford, US

Internal Auditing India

West Chester, Pennsylvania, US

Quality Systems For Phase 3 TTI

Global SME

Facility Laboratory Designer and Lean Lab Management

Virtual Biologic Device( Combination Product ) Quality Management System IND Start Up

Taking a break from the Corporate America and developing a new business and product.

Domestic and International Remediation Services for Data Integrity, Compliance Issues, 483's and Warning Letters, Consent Decrees and potential Import Band Alerts., Former FDA Agents, Former FDA Lawyers in addressing regulatory findings.

West Chester, Pennsylvania, US

Lab redesign and steam line testing processes.

West Chester, Pennsylvania, US

Confidential Information at this time.

Facility Build and Validation Consultant for Research and Development Company that's going ISO13485- "Quality"

Class III Medical Devices and Solid Dose Pharmaceuticals; commissioning of facilities, utilities validation, cleanroom certification, equipment set up and validate manufacturing processes in an ISO class environment.

503A Sterile Aseptic Facility Relocation Project Design Review. Preformed Verification Activities from prior consulting audits and compliance review to the new 503A and 503B Compounding Regulations.

Durham, North Carolina, US

Durham, North Carolina, US

Performed cGMP baseline audit inspections, as part of the Consent Decree with a confidential Pharmaceutical client in US and Asia.

Solid Oral Dosage, Sterile Aseptic and Medical DeviceHealth Authorities Remediation AssistanceWarning LettersConsent Decree Auditing Program Management Quality Systems Import Ban Solutions

Project managed a team of 12 consultants on lifting a warning letter on a controlled substances/ liquid mfg site within six months. By utilizing the 21 Quality Element Approach developed by Smart Consulting Group and Validating Controlled/Liquid Product to the new FDA Guidance for Validation lead this project to success.

My services to assist a third party consultant company to Quintiles were project manage an audit team of 10 for customer complaints,bio studies,and laboratory data; audit team consisted of 4 former FDA consultants,and team of experience subject matter experts. Assisted the VP of the project on presentations to the executive team, assist team in response.

Santa Clarita, CA, US

Assisted management with the relocation expansion project for a class 3 medical device for utilities and process validation.

Assisted on a Due Diligence audit on quality systems on a liquid company

Marlborough, MA, US

Validation Utilities/Process and Quality Consultant Medical DeviceAssisted on the Relocation of the Facilities 54 Million Dollar Project

REVELANT WORK HISTORY:2008 – Sept 2008 Bioness Inc. Facilities Consultant for a Medical Device Company, Utilities ValidationValencia, CA

Hayward, California, US

Directed and managed project teams with client and 10+ validation and quality consultants for a relocation expansion project

• Lead investigator for complex investigations for the manufacturing areas investigation experierence include but not limited to: Glatt, Tablet Coaters, Packaging,Granulation stages.
• Perform complex and non-complex investigations for non-conformance deviations, laboratory out of specification results, and customer complaints.
• Track deviations through completion and approval of the report.
• Present investigation findings to the management review board (MRB).
• Identify root cause(s), provide and recommend corrective and preventive actions for deviations of procedures.
• Update, revise and maintain databases to meet Quality Assurance reporting requirements.

US

FPP- FLORIDA PHARMACEUTICAL PRODUCTSLooking for manufacturing facilities to manufacture generic drugs for FPP.