We solve FDA problems
Consult with former FDA professionals with over 30 years industry experience!
Welcome and thank you for visiting! FDA training and consulting is the cornerstones of our business. Whether you are reacting to a recent FDA Warning Letter, as many of our clients are, or proactively seeking assistance, IQCDS can be your solution.
We have taken many of the training courses developed over the years and formalized them for delivery at your company. We have some of the same trainers that trained the FDA Investigators – as well as content. On average our consultants and trainers bring over 30 years average experience in the FDA regulated environment – most of which formerly served at the FDA.
FDA Consulting & Training Services
Quality Solutions
Our consulting work is performed through Saldana & Associates, our original company. We have formalized International Quality Consulting as the training company and focus for all of our activities. As the name implies it focuses on quality through information and assistance.
Our work is centered on your success. Our expertise includes specific QSR/GMP related items to general QSR/GMP training or more complex quality system implementation efforts we are focused on your success. We perform company wide analysis, training, consulting and auditing.
As we move into Webinars and other media, we will continue to provide quality related training in a quality manner. Your solution may involve a brief contact or a multi-year commitment. We are geared up to assist you.
Our associates are highly experienced in all phases of quality system for QSR/GMP such as validation, auditing, CAPA, management controls, document control, change control, design control, and production/process control. We work with top management in doing it right the first time – from the initial gap analysis to the implementation and continuous improvement. We can help develop compliance master plans and FDA update submissions. Our associates also provide project management, which is vital to providing metrics and oversight to the projects. We also can assist in your culture change and communication efforts.
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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