Roque Redondo
Sr. Technical Consultant Mentor Technical Group
Mr. Roque Redondo has over 34 years of experience including international experience in the pharmaceutical / biotechnology / medical devices industry in the Validation, QA, Engineering / Compliance / Regulatory Areas. He was part of the Sr. Management Team during the implementation of the remediation activities related to Schering-Plough Consent Decree. His experience includes Data Integrity, Operations, Serialization, Validation, QA, Engineering and Technical Services. Mr. Redondo has offered over 50 different courses related to Data Integrity and over 100 different courses in the Validation area as well. In addition, he has written 5 articles related to Data Integrity. Mr. Redondo has a nice blend of experience that help him understanding the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills. Finally, Mr. Redondo also has knowledge and experience in CSV, 21 CFR Part 11, CSA, Process and Cleaning Validation.
• Responsible for Computerized System Validation (CSV), Equipment Qualification, and 21 CFR Part 11 Programs.
• Responsible for Serialization Program at Vantage Consulting Group PR Office
• Member of Corporate Teams developing & implementing CSV & Part 11 programs
• Hands on experience in CSV including Software Validation, Process Validation, Equipment Qualification, Utilities & Facilities Qualification, Part 11 Compliance, development and implementation of different corporate programs, GAMP4 & GAMP5, etc.
• Manage regulatory audits provided by Site Certifiers Auditors and by FDA during Consent Decree
• Attended over 10 courses in Data Integrity practices including Human Error, Programs Development & Implementation, Concepts, etc.
• Project management for validation efforts, including development, execution, review & approval of IQ/OQ/PQ Protocols for complex projects
• Experienced in Technology Transfer project activities
• Experienced in the development, revision & approval of SOPs, Deviations, CAPA’s, Change Control, Audits, Pre-Approval activities, Batch Records, etc.
• Change Control Program Manager
• Yellow Belt & Green Belt Training
• Technical Personnel Management for over 15 years
• Support clients analyzing finding related to Data Integrity.
