Expert Details
EU GMP and Quality Systems
ID: 723155
Ireland
educated to bachelors degree level with many years experience in the field
The Client retained Expert of Employer to help and guide it towards obtaining a Manufacturing Licence from Irish Medicines Board, IMB. Expert worked with the client for approximately 26 days. Project started in May 2005, first inspection from IMB was in August 2005. There were no critical deficiencies and Licence was issued by IMB in November 2005 without a second inspection.In April 2004 the client had been audited by an inspectorate and had received 2 critical deficiencies and 10 major deficiencies. The Client retained Expert of Employer to help and guide it towards addressing the deficiencies. Expert worked with the client for approximately 70 days. Project started in June 2004, the follow on inspection by the inspectorate was in December 2005. There were no critical deficiencies and 4 major deficienciesThe Irish Medicines Board (IMB) is the Competent Authority in Ireland charged with the responsibility of licensing companies in Ireland that wish to perform clinical trials on Investigational Medicinal Products. The license it issues to successful applicants is known as a Manufacturing license (ML). The rules governing the manufacture of medicinal products are called the EU Guide to Good Manufacturing Practices (GMP) Volume IV. There is a dedicated annex in the Guide relating specifically to the production and importation of IMPs.
Status of Client when Employer was retained was as a clinical trials organisation. The Client was based in Ireland. Client at this time-point was not regulated by the IMB. Staff number was 25. None of the staff had good knowledge of EU GMP.
The Client retained Expert of Employer.com to help and guide it towards obtaining a Manufacturing Licence from IMB. Expert worked approximately 8 days with the client. Project started in March 2005. The first inspection from IMB was in October 2005. There were no critical deficiencies and Licence was issued by IMB in December 2005.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: BS | Subject: Science | Institution: University College Galway |
| Year: 1997 | Degree: MS | Subject: Biochemistry | Institution: University College Galway |
| Year: 2000 | Degree: Diploma Pharmaceutical Manufacturing Technology | Subject: Pharmacy | Institution: Trinity College Dublin |
| Year: 1987 | Degree: Diploma | Subject: Education | Institution: University College Galway |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: Senior Consultant | Department: Consulting |
Responsibilities:He provides the following services:Auditing Qualified Persons Commercial Laboratory Accreditation Prepare External Regulatory Audits Test Method Validation Process Validation Training Courses Up-skilling |
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| Years | Employer | Title | Department |
| Years: 2001 to 2003 | Employer: Wyeth | Title: Quality Manager | Department: Quality |
Responsibilities:He held the position of Quality Manager in a major manufacturer and packer of solid dose forms for human use, Responsible for quality assurance and quality control |
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| Years | Employer | Title | Department |
| Years: 1999 to 2001 | Employer: Baxter | Title: Senior Microbiologist | Department: Microbiology |
Responsibilities:He held the position of Senior Microbiologist in a major producer of sterile Parenteral products for human use. Responsible for all microbiology testing of large volume solutions |
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| Years | Employer | Title | Department |
| Years: 1991 to 1999 | Employer: Fort Dodge Laboratories | Title: QC Manager | Department: Quality Control |
Responsibilities:Manage laboratory testing for all bacterial and viral vaccines |
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| Years | Employer | Title | Department |
| Years: 1989 to 1991 | Employer: Teagasc | Title: Senior Research Scientist | Department: Research |
Responsibilities:Research into animal diseases |
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| Years | Employer | Title | Department |
| Years: 1986 to 1989 | Employer: University College Galway | Title: Research Associate | Department: Biochemistry |
Responsibilities:He was responsible for conducting research into disgnostic tests for detecting hormones in human specimens. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2005 to 2005 | Country / Region: Turkey | Summary: Review compliance in manufacturing site against EU standards. |
| Years: 2005 to 2005 | Country / Region: USA | Summary: Review compliance in manufacturing site against EU standards |
| Years: to Present | Country / Region: Bulgaria | Summary: Review compliance in manufacturing site against EU standards |
| Years: to Present | Country / Region: Brazil | Summary: Review compliance in manufacturing site against EU standards for API and Finished Pharma |
| Years: to Present | Country / Region: The Netherlands | Summary: Review compliance in manufacturing site against EU standards |
Additional Experience
| Training / Seminars |
|---|
| The expert has delivered training courses on following subjects: 1. Good Manufacturing Practices (GMP) for the Pharmaceutical and Allied Sectors 2. Good Laboratory Practices (GLP) for the Pharmaceutical and Allied Sectors 3. Good Manufacturing Practices (GMP) as applied to Investigational Medicinal Products (IMP) 4. Internal Auditing and Self Inspection within the Pharmaceutical and Allied Sectors 5. Good Distribution Practices (GDP) for the Pharmaceutical and Allied Sectors 6. The History of Drug Development 7. Supply Chain Integrity and Tamper Proofing in Pharmaceutical Manufacturing and Distribution 8. Business Writing Skills 9. Interview Skills 10. Managing Difficult People 11. Performance Coaching Skills 12. Training for Managing People 13. Understanding Team Working 14. Time Management 15. Good Documentation Practice 16. Writing Effective Standard Operating Procedures and Process Documents 17. Upskilling |
| Vendor Selection |
|---|
| He has audited api and finished product plants in Ireland, Netherlands, Italy, Spain, Portugal, Turkey and USA. |