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 Expert  723155

Expert in EU GMP and Quality Systems


Available for your Consulting and Expert Witness Needs

Ireland
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Educated to bachelors degree and masters level in biochemistry with many years experience in this field
 • 

biochemistry

 • 

European Union's Good Manufacturing Practice

educated to bachelors degree level with many years experience in the field
 • 

microbiology


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution   Honors
1986   BS   Science   University College Galway   General
1997   MS   Biochemistry   University College Galway  
2000   Diploma Pharmaceutical Manufacturing Technology   Pharmacy   Trinity College Dublin  
1987   Diploma   Education   University College Galway  

Work History:
Years   Employer   Department   Title   Responsibilities

2003 to

 

(Undisclosed)

 

Consulting

 

Senior Consultant

 

He provides the following services:

Auditing Qualified Persons Commercial Laboratory Accreditation Prepare External Regulatory Audits Test Method Validation Process Validation Training Courses Up-skilling

2001 to 2003

 

Wyeth

 

Quality

 

Quality Manager

 

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

1999 to 2001

 

Baxter

 

Microbiology

 

Senior Microbiologist

 

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

1991 to 1999

 

Fort Dodge Laboratories

 

Quality Control

 

QC Manager

 

Manage laboratory testing for all bacterial and viral vaccines

1989 to 1991

 

Teagasc

 

Research

 

Senior Research Scientist

 

Research into animal diseases

1986 to 1989

 

University College Galway

 

Biochemistry

 

Research Associate

 

He was responsible for conducting research into disgnostic tests for detecting hormones in human specimens.


Career Accomplishments:
Licenses/Certifications

Qualified Person (under EU legislation)


Consulting Services:
Selected Consulting Examples:
  • The Client retained Expert of Expert's Firm 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 Expert's Firm 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 deficiencies
  • The 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 Expert's Firm 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 Expert's Firm.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.
Recent Client Requests:
  • Expert for consulting on help to get EU-GMP Certificate.
  • GMP regulations expert for consulting on audit of API formulation house for suitability to manufacture pharmaceutical products.
  • EU cosmetic expert for consulting on advising CTO to meet 76/768/EEC requirements.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting in litigation involving building a materials recovery facility next to a pharmaceutical plant in Northern Ireland.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2005 to 2005   Turkey   Review compliance in manufacturing site against EU standards.
2005 to 2005   USA   Review compliance in manufacturing site against EU standards
to   Bulgaria   Review compliance in manufacturing site against EU standards
to   Brazil   Review compliance in manufacturing site against EU standards for API and Finished Pharma
to   The Netherlands   Review compliance in manufacturing site against EU standards

Additional Skills and Services:
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

Supplier and Vendor Location and Selection

He has audited api and finished product plants in Ireland, Netherlands, Italy, Spain, Portugal, Turkey and USA.


 

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