Training Services
IQCDS provides training programs to meet the needs of both the device and drug industries worldwide as it relates to FDA matters. We can provide both off the shelf and custom training programs in:
- QSIT
- Quality Systems
- CAPA
- Investigations
- Auditing
- Sterilization
- Validation
- Quality Systems for Devices & Drugs
- FDA Inspection Training
We also offer training on FDA processes, such as how to handle post-inspection and compliance issues.
We offer in-house training which will give you the essential knowledge needed to succeed. We employ former FDA Investigators, and attorneys specialized in FDA law. Our industry associates are each recognized nationally and internationally for their knowledge and training.
We work with you to develop a customized training program – using our basic materials and content – which will be related to your own company’s products and processes. We can mix and match courses to make efficient use of resources and your limited time available for training. This content will be delivered by our expert trainers at your site or at a nearby hotel, depending on the size audience and availability of training rooms at your site. We have trained entire companies (approximately 1000 employees) over brief periods, including evening shift employees.
Quality Systems for
Medical Devices
Basic Drug Good
Manufacturing Practices (GMPs)
Validation
Training
FDA Inspection
Readiness Training
Design Controls
Program
Corrective & Preventive
Action (CAPA) Training
How to Conduct
Investigations (Basic)
Auditor
Training
Client Recognitions & Endorsements
We are extremely grateful for the recognitions & endorsements of our clients and we hope to include you among them.
1995 Letter of appreciation for my quality and professionalism from Regulatory Affairs Consultant, Glen A. Dunki-Jacobs. (Phacoemulcification Devices)
2009 Letter of recommendation from Johnson & Johnson, for providing compliance consulting services.
1999 Letter of appreciation from Medtronic Anurex facility. As a result of my audit the facility passed a FDA pre-PMA inspection without FDA-483s.
1993 Letter of appreciation for my thorough and probing investigation from Pegasus Research Corporation, President, Kenneth G. Miller. (Humidifiers)
2007 Letter of appreciation for an excellent job in identifying weaknesses in company system, providing constructive solutions, clearly explaining the FDA interpretations of various clauses in the regulations, and allowing the staff to experience the interviewing techniques of a FDA investigator. Staff was comfortable with his conversational and interviewing style.
2009 Letter of recommendation from ASP for consulting services related to performing a comprehensive gap analysis and redesign of company’s Design Control process.
1986 Outstanding Young Men of America for religious and professional contribution at the University of Puerto Rico, Regional College Administration, submitted by Jorge Valentin, Dean for Student Affairs.
1995 Letter of appreciation from Patrick Bouveret, Plant Manager for my quality and professionalism from Laboratory Prodimed, France (Endometrial Suction Curette).
1997 FDA Cash Award for exceptional service as a Team Leader, for performing several high priority PMA/510(k) assignments and for my participation with the Global Harmonization Task Force auditing cadre.
1997 Letter of commendation from Willy Rusch, Germany, for my thorough inspection and extremely thorough analysis and grasp of their processes (catheters).
2003 Letter of recommendation from Guidant Co. (Catheters/Drug Delivery Systems)
1995 Letter of appreciation for my commendable performance from Instrumentation Laboratory, Italy, Vice President/Quality Assurance, World Wide, James C. McGaha, Jr. (IVDs).
1995 Letter of appreciation for my valuable information from Venusa, Ltd, Italy, President /CEO, Cesare Gagliardoni (IV Sets).
International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.
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