He conducts comprehensive audits to identify significant operational challenges and provides technical support in drafting timely responses to the FDA on behalf of his clients.
LAKE FOREST, CA, September 18, 2024 /24-7PressRelease/ -- Dennis Saldana has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.
Well-regarded for more than 30 years of expertise in the areas of quality compliance, drug manufacturing and medical device quality assurance, Mr. Saldana has distinguished himself as the president and chief executive officer of International Quality Consulting. Originally known as Saldana & Associates, IQCDS leverages the considerable experience and professional opinion of several former employees of the Food and Drug Administration (FDA) in addressing a wide range of industry issues, including the evaluation of products, risk analysis, process validation, human resources, laboratory research, project management, and facility inspection, to name only a few.
Drawing from past employment with the FDA in his own right, Mr. Saldana conducts comprehensive audits to identify significant operational challenges and provides technical support in drafting timely responses to the FDA on behalf of his clients. His knowledge of the field has been of considerable value to companies that struggle to comply with FDA regulations, addressing noncompliance issues and developing corrective actions. Additionally, his background in the corporate world equips him with a deep understanding of weak points within the regulatory system and how to address them effectively. Highly acclaimed for his expertise, Mr. Saldana has consulted as far afield as Taiwan, where he once performed a 12-day inspection of all the major drug manufacturing facilities in the country and presented his findings to representatives of the Republic of China Food and Drug Administration.
Initially earning a Bachelor of Science in biology and chemistry at the Inter American University of Puerto Rico in 1977, Mr. Saldana went on to serve as a consumer safety officer at the FDA, where he was responsible for auditing high technological manufacturing companies domestically and internationally in the area of medical devices. Completing more than 100 inspections during this time, he advanced to the role of team leader for the Los Angeles District Medical Device Team and frequently presented on the subject of quality system regulation and good manufacturing processes. Following this period, Mr. Saldana went on to work in positions of leadership within the private sector, including as a quality and regulatory manager at Baxter Healthcare, a senior regulatory compliance specialist with the Medtronic Heart Valves Division, a regulatory compliance manager at Celltech-Medeva Pharmaceuticals, and a quality assurance manager with Allergan Pharmaceuticals.
A former member of the American Society for Quality, Mr. Saldana holds extensive certifications in his field, including as a Quality Lead Auditor for International Quality Management Systems, in medical device process valication, and in Design Control Requirements and Industry Practice via the Association for the Advancement of Medical Instrumentation, among others. In honor of his excellent performance over the course of decades, he has received several letters of recommendation from past employers and organizations with which he has consulted, such as Johnson & Johnson.
Among his career highlights, Mr. Saldana is most proud to have cultivated an ability to communicate with and alleviate the concerns of people from all over the world. In accounting for his success, he largely credits his canniness in tracking down compliance-related issues, as well as his strong and comprehensive work ethic. Looking toward the future, he hopes to begin scaling back his business endeavors and become more selective with his work, with the ultimate aim of entering a well-deserved retirement in the years to come.
About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.
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