This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product development, regulatory submissions, initiating/overseeing company-wide V&V planning, using a risk-justified approach and responsible for some of the areas identified herein, certainly will benefit. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the V&V process with product, process, software and impact on the QMS from start to finish, with key emphasis on regulatory compliance and governance, including.
The seminar will also expound on several areas covering examples, and for clarification and discussion points with the audience, including but not limited, to the following: design validation; sterilization validation; test method validation; software validation; process validation; design verification and process verification; DQ, IQ, OQ, PQ and other areas associated with the QMS. We will evaluate V&V protocols; how to implement and evaluate realistic equipment/process requirements and specifications. We will review various documentation and materials that simplify product, process and equipment, software VT&V and related to the QMS to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this seminar will address these important topics with the audience.
Speaker
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
The seminar will also expound on several areas covering examples, and for clarification and discussion points with the audience, including but not limited, to the following: design validation; sterilization validation; test method validation; software validation; process validation; design verification and process verification; DQ, IQ, OQ, PQ and other areas associated with the QMS. We will evaluate V&V protocols; how to implement and evaluate realistic equipment/process requirements and specifications. We will review various documentation and materials that simplify product, process and equipment, software VT&V and related to the QMS to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this seminar will address these important topics with the audience.
Speaker
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
