Sudha Gupta

About Me

Sudha Gupta currently has over 10 years of management experience in the Medical Device and Pharmaceutical industry. Over the course of her career she has obtained extensive experience in implementation and maintenance of FDA compliant Quality Systems as related to 21 CFR Part 820 and ISO 13485. Her extensive experience in Quality Systems implementation supplemented with her experience in post market-surveillance, risk management, and data-driven continuous improvement has enabled her to be successful in finding Quality System solutions that are not only compliant with applicable regulations but are in line with business objectives. Her wide array of experience and out of the box thinking has enabled her to implement, manage and subsequently lead fully compliant quality management systems. Her calm, confident and persuasive demeanor complemented with her expert level knowledge of medical device standards and regulations has enabled her to be the “go-to” person when facing FDA investigators and Notified Body Assessors. She has successfully hosted and participated several rigorous FDA inspections throughout her career and countless customer and ISO audits. She prides herself in being the front line of defense and ensuring the company she represents puts its best foot forward when being reviewed by any outside agency.

She has learned over the years that it is not the management of quality that makes a business successful but rather the quality of management. It is imperative that any QA or Compliance organization within the business not only strive to maintain a healthy balance between business and compliance objectives but also serve as internal consultants so as to be able to influence the decision making process using a risk based approach.

Her comprehensive experience, and background will help you understand how you can help your organization not only stay compliant to applicable standards and regulations but will also help facilitate improvements to products and processes so that regulatory compliance becomes a natural outcome rather than a singular objective.

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