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OUR QUALIFICATIONS
Dale Enright, B.Sc., P.Chem.
Education
- 4 year B.Sc. with a Major in Organic Chemistry and a Minor in Math/Statistics.
- He also has done post-graduate research in Pharmaceutical Chemistry, Phytochemistry and Veterinary Medicine.
QA Training
- Understanding GMP: 1 hour video and exam (Micron International Video)
- Statistical Process Control: 8 hour in-house course
- Internal Auditor (for ISO 9000) - 21 hours Productivity Improvement Centre
- GMP for NHPs: 8 hours (NHPD - June 21, 2002)
- Total Quality Control (TQM): 24 hour in house course (AMOCO Petroleum)
- Quality Assurance for the Environmental Analytical Laboratory: 30 hours (Northern Alberta Institute for Technology - NAIT)
- WHMIS for the Laboratory: 4 hour in-house course on three separate occasions
- Transportation of Dangerous Goods (TDG): 4-hour in-house course on three separate occasions
QA Experience
- Since June of 1999, Dale has helped more than 50 different companies to either design, implement and audit QA programs for the pharmaceutical, nutraceutical, medical device, chemical, cosmetic and food industries. These companies are located throughout Western Canada and as far away as Australia.
- He is also the QA Officer for various importers and distributors of pharmaceuticals.
- He has trained over 1,000 people either at industry conferences or in-house at various client facilities.
- As a former Laboratory Manager in the Oil and Gas industry, Dale designed and implemented ISO 9000, then subsequently upgraded it to ISO 17025. This implementation process included writing well over 75% of all the analytical & calibration procedures, forms, labels and checklists. Dale was then responsible for developing the protocol for the internal inspections and performing them, as well as for maintaining the program.
- Dale was then recruited by a competitor of the company referred to above, as their Chemical Plant Manager. Part of his duties was to implement ISO 9000 for their chemical production facilities and ISO 17025 for their laboratory.
- To date, Dale has developed, revised and audited well over 3,000 procedures. These procedures include the maintenance, cleaning, operation and calibration of various rigidly-regulated production equipment, as well as their analytical and calibration equipment.
- Dale has developed, inspected and revised well over 200 validation protocols for production, analytical and calibration equipment.
- On behalf of our clients, Dale performed more than ten ISO 17025 / GLP inspections of various commercial contract laboratories to determine if their analytical / calibration methods meet our clients' (and Health Canada's) expectations. This includes the inspection of the QC testing methods for finished pharmaceuticals, along with inspection of their calibration & validation protocols.
- Prior to working in the Oil and Gas industry, Dale set up the GLP / ISO 17025 program for a university's pharmaceutical / medical research lab and for one of Agriculture Canada's laboratories.
Gord Johnston, B.Sc., M.Sc.
Education
- M.Sc. in Experimental Medicine / Human Physiology from the U of Alberta.
- 4 year B.Sc. in Microbiology and Food Sciences from the U of Alberta.
- 3 year Diploma in Chemistry/Biological Sciences from the Northern Alberta Institute of Technology (NAIT).
QA Training
- GMP for NHPs Regulations: 8 hours (NHPD – Nov. 2003)
- 4-day NHPD workshop on the new NHP regulations (NHPD – Nov. 2003)
- At least 200 hours of in-house training.
QA Experience
- Gord created and implemented a QA program during his 10 years as Laboratory Manager and Researcher in a U of BC research laboratory.
- Since starting April 1, 2003 Gord has assisted in one Gap Analysis and two GMP implementations with Dale.
- Gord has been proactive in creating several of the ICS internal checklists for Gap analyses and GMP implementations.
- He continues with daily intensive QA training with Dale.
Tammy Patterson, Director of Operations
Education
- 2-year diploma in Resort Management, with specialization in Marketing and Advertising.
QA Training
- Working with Dale for the past 10 years, she has received at least 1,000 hours of in-house QA training.
QA Experience
- Assisted Dale in at least 10 pharmaceutical GMP audits and Gap Analyses.
- Reviewed, edited and audited at least 400 pharmaceutical SOPs.