ROBERT DI LONARDO, Consultant and Founder

Having over ten years’ experience in the regulated pharmaceutical industry, I can effectively communicate compliance issues to stakeholders and assist in the implementation of corrective and preventive actions.  I have an interest in process improvement and assisting in achieving greater efficiency and compliance through root cause and gap analysis, applying risk management, assessing quality trends in order to drive a continuous improvement program, providing training, and in writing and implementing procedures.  My extensive experience in preparing and hosting client audits and government inspections have not only helped me identify areas of noncompliance before they become a risk to the business, but it has given me the knowledge for proper mitigation by defining remediation plans and monitoring their execution to ensure the issues are suitably addressed and ensuring site readiness for future inspections.

My experience as a project manager has provided me with the skills for proper planning, management, and risk assessment while coordinating these efforts across a large and diverse group of individuals, and across multiple sites internationally.  I have provided guidance to ensure projects were run according to the established scope and required regulations, formulated strategies and made decisions, while maintaining the project plan on schedule with appropriate resources and identifying dependencies to ensure suitable actions were agreed upon and effectively resolved.  I have excellent communication skills; not only effectively delegating tasks efficiently while ensuring responsibility and accountability is properly assigned and communicated to the right individuals, and motivating project team members while building a relationship of trust and commitment, but in providing status updates to stakeholders and executive management in a timely manner.

I have knowledge and experience in applying US FDA and OECD GLP regulations, US FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11, US FDA and EudraLex Volume 4 GMP regulations, and FDA Quality System Regulation and guidelines.  I am a Registered Quality Assurance Professional (RQAP-GLP) with the Society of Quality Assurance, and I am an active member of both the Society of Quality Assurance and its Canadian chapter.

My extensive experience in quality and project management can be applied to any discipline requiring attention to detail, accuracy and precision.  I am a results-oriented person who thrives on a challenge and pride myself on consistently achieving high levels of performance.  I am accustomed to a fast paced environment, where multi-tasking is a necessity to meet deadlines, and requiring the use of both analytical and interpersonal skills daily.  I am eager to have an opportunity to work with your organization and I would welcome the opportunity to meet with you to discuss how my qualifications can meet your needs.

Knowledge and experience with the following regulations, standards, and guidelines

• 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies (1987).
• 21 CFR Part 11: Electronic Records / Electronic Signatures Rule (1997).
• 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (1999)
• 21 CFR Part 211: Current Good Manufacturing Practice in Manufacturing Finished Pharmaceuticals (1999)
• OECD Principles on Good Laboratory Practice ENV/MC/CHEM(98)17
• ENV/JM/MONO(2016)13 OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 17 Advisory Document of the Working Group on Good Laboratory Practice Application of GLP Principles to Computerised Systems
• EudraLex, Volume 4, Good Manufacturing Practice (GMP)
• Eudralex, Volume 4, Good Manufacturing Practice (GMP) Guidelines Part 1, Annex 11 Computerised Systems
• Eudralex, Volume 4, Good Manufacturing Practice (GMP) Guidelines Part 1, Annex 15 Qualification and validation
• FDA Guidance for Industry: General Principles of Software Validation (2002).
• FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application (2003).
• FDA Glossary of Computerized System and Software Development Terminology (2004).
• GAMP 5 (Good Automated Manufacturing Practice), Guide for Validation of Automated Systems (2008).
• Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance (Red Apple II Guide) (2008).
• ICH guideline Q9 on quality risk management
• ICH guideline Q10 on pharmaceutical quality system