Professional Certificate in Diagnostic Industry Guidelines
-- ViewingNowThe Professional Certificate in Diagnostic Industry Guidelines is a crucial course for healthcare professionals seeking to stay updated with the latest industry regulations and best practices. This program covers essential guidelines from renowned organizations like FDA, CLIA, and CAP, ensuring learners can navigate the complex regulatory landscape with ease.
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⢠Regulatory Affairs in Diagnostic Industry: Overview of domestic and international regulations, guidelines, and standards affecting the diagnostic industry
⢠Clinical Laboratory Improvement Amendments (CLIA): Compliance requirements, certification, and inspection process for diagnostic laboratories
⢠Quality Management Systems (QMS): Implementation and maintenance of QMS in the diagnostic industry, including ISO 13485 and ISO 15189
⢠Good Laboratory Practice (GLP): Principles, compliance, and documentation requirements for GLP in diagnostic testing
⢠Good Manufacturing Practice (GMP): GMP regulations and guidelines in diagnostic manufacturing, including FDA and EU requirements
⢠Risk Management in Diagnostics: Risk assessment, mitigation, and management in the diagnostic industry, including ISO 14971
⢠Medical Device Single Audit Program (MDSAP): Overview of MDSAP, its benefits, and the audit process
⢠In Vitro Diagnostic (IVD) Regulations: IVD regulations, guidelines, and classification in major markets, such as EU, US, and China
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