2-20.pptx

TRAINING MAY BE THE SINGLE MOST IMPORTANT ASPECT OF QUALITY’s JOB… If you have learned what is right…you know how to recognize what is wrong. www.ctkbiotech.com • What Does the FDA Require?      www.ctkbiotech.com Management Commitment – Management Review Personal Accountability Follow th...

TRAINING MAY BE THE SINGLE MOST IMPORTANT ASPECT OF QUALITY’s JOB… If you have learned what is right…you know how to recognize what is wrong. www.ctkbiotech.com • What Does the FDA Require?      www.ctkbiotech.com Management Commitment – Management Review Personal Accountability Follow the recipe – or Change it! GDP – Good Documentation Practices – Evidence! Find and Fix your own problems! – CAPA, Internal Audits QUALITY DEFINED WHAT IS QUALITY? The simple definition: Conformance to requirements of a process or product Re-stated: A quality process – or a quality product – is one that conforms to requirements QUALITY DEFINED • In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. • The totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs. • “The standards cannot create Quality…ISO (and FDA QSR’s) are just an empty bookshelf for you to design and build your processes on…Quality is achieved when you achieve the minimum requirement of a specified performance standard. Quality is a specified performance range…Toyota Corolla and a top of the line Mercedes Benz are “quality cars”. • Totality of characteristics which act to satisfy a need www.ctkbiotech.com What is Quality Management? • The act of overseeing all activities and tasks needed to maintain a desired level of excellence. This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. www.ctkbiotech.com FDA REGULATION…. WHY? The QS Regulation applies to finished device manufacturers who intend to commercially distribute medical devices.” 21 CFR Part 820 – General Provisions (a) (1) 3rd sentence…“The requirements in this part are intended to ensure that finished devices will be safe and effective…” (c) Authority…”The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.” WHAT DOES FDA REGULATION REQUIRE? OVERVIEW OF 21 CFR Part 820 Quality System Regulation Management Responsibility QUALITY AUDIT • …Conduct audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. • Conducted by those not having direct responsibility for the areas being audited. • Take Corrective Action • Re-audit if you need to • Management needs to review the results www.ctkbiotech.com Management Responsibility PERSONNEL • Shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. • Identify training needs – Train all personnel • Workers must be aware of device defects that may occur if the job is not accomplished properly • Those who perform verification and validation activities need to be aware of defects and errors that they might encounter during those activities… www.ctkbiotech.com PERSONAL ACCOUNTABILITY …independence and authority…. • Take full responsibility for your position and duties • KNOW your job – do it correctly – be competent – continue to learn • The law says YOU have been empowered to do the best job you can for CTK – and – to do it the “right” way – YOU are obligated to follow the FDA regulations and all established processes and procedures. Empowered: to give power or authority to, to authorize, especially by legal or official means… to enable….to permit… www.ctkbiotech.com