Professional Certificate in Regulatory Affairs for IVD Compliance Strategies
-- ViewingNowThe Professional Certificate in Regulatory Affairs for IVD Compliance Strategies is a crucial course for professionals seeking expertise in the regulatory affairs sector, particularly in the In Vitro Diagnostic (IVD) industry. This program's importance lies in its ability to provide learners with comprehensive knowledge of global IVD regulations, compliance strategies, and quality management systems.
7,259+
Students enrolled
GBP £ 149
GBP £ 215
Save 44% with our special offer
ใใฎใณใผในใซใคใใฆ
100%ใชใณใฉใคใณ
ใฉใใใใงใๅญฆ็ฟ
ๅ ฑๆๅฏ่ฝใช่จผๆๆธ
LinkedInใใญใใฃใผใซใซ่ฟฝๅ
ๅฎไบใพใง2ใถๆ
้ฑ2-3ๆ้
ใใคใงใ้ๅง
ๅพ ๆฉๆ้ใชใ
ใณใผใน่ฉณ็ดฐ
โข Regulatory Foundations for IVDs: Understanding the legal and regulatory landscape of In Vitro Diagnostic (IVD) devices, including key regulations and directives such as EU IVD Regulation 2017/746, FDA regulations, and international standards. โข Quality Management Systems: Implementing and maintaining a Quality Management System (QMS) according to ISO 13485, focusing on design control, document control, corrective and preventive action (CAPA), and risk management. โข Clinical Evidence and Evaluation: Gathering and evaluating clinical evidence to demonstrate compliance with regulatory requirements, focusing on clinical performance, analytical performance, and stability studies. โข Labeling and Instructions for Use: Creating compliant labeling and Instructions for Use (IFU) for IVD devices, addressing language requirements, symbols, and warnings, as well as understanding the importance of UDI (Unique Device Identification) and IFU usability. โข Technical File Preparation: Compiling and maintaining technical files for IVD devices, including design dossiers, risk management files, and post-market surveillance reports, in accordance with regulatory requirements. โข Post-Market Surveillance and Vigilance: Implementing and maintaining post-market surveillance and vigilance programs, including reporting adverse events, conducting post-market clinical follow-up, and implementing corrective actions when necessary. โข Regulatory Audits and Inspections: Preparing for and managing regulatory audits and inspections, including understanding the role of Notified Bodies and regulatory agencies, and responding to audit findings and inspection observations. โข Global Market Access and Regulatory Strategies: Developing and implementing global market access and regulatory strategies for IVD devices, addressing country-specific requirements, registration processes, and market surveillance. โข Ethical Considerations in Regulatory Affairs: Understanding and applying ethical considerations in regulatory affairs,
ใญใฃใชใขใใน
ๅ ฅๅญฆ่ฆไปถ
- ไธป้กใฎๅบๆฌ็ใช็่งฃ
- ่ฑ่ชใฎ็ฟ็ๅบฆ
- ใณใณใใฅใผใฟใผใจใคใณใฟใผใใใใขใฏใปใน
- ๅบๆฌ็ใชใณใณใใฅใผใฟใผในใญใซ
- ใณใผในๅฎไบใธใฎ็ฎ่บซ
ไบๅใฎๆญฃๅผใช่ณๆ ผใฏไธ่ฆใใขใฏใปใทใใชใใฃใฎใใใซ่จญ่จใใใใณใผในใ
ใณใผใน็ถๆณ
ใใฎใณใผในใฏใใญใฃใชใข้็บใฎใใใฎๅฎ็จ็ใช็ฅ่ญใจในใญใซใๆไพใใพใใใใใฏ๏ผ
- ่ชๅฏใใใๆฉ้ขใซใใฃใฆ่ชๅฎใใใฆใใชใ
- ่ชๅฏใใใๆฉ้ขใซใใฃใฆ่ฆๅถใใใฆใใชใ
- ๆญฃๅผใช่ณๆ ผใฎ่ฃๅฎ
ใณใผในใๆญฃๅธธใซๅฎไบใใใจใไฟฎไบ่จผๆๆธใๅใๅใใพใใ
ใชใไบบใ ใใญใฃใชใขใฎใใใซ็งใใกใ้ธใถใฎใ
ใฌใใฅใผใ่ชญใฟ่พผใฟไธญ...
ใใใใ่ณชๅ
ใณใผในๆ้
- ้ฑ3-4ๆ้
- ๆฉๆ่จผๆๆธ้ ้
- ใชใผใใณ็ป้ฒ - ใใคใงใ้ๅง
- ้ฑ2-3ๆ้
- ้ๅธธใฎ่จผๆๆธ้ ้
- ใชใผใใณ็ป้ฒ - ใใคใงใ้ๅง
- ใใซใณใผในใขใฏใปใน
- ใใธใฟใซ่จผๆๆธ
- ใณใผในๆๆ
ใณใผในๆ ๅ ฑใๅๅพ
ไผ็คพใจใใฆๆฏๆใ
ใใฎใณใผในใฎๆฏๆใใฎใใใซไผ็คพ็จใฎ่ซๆฑๆธใใชใฏใจในใใใฆใใ ใใใ
่ซๆฑๆธใงๆฏๆใใญใฃใชใข่จผๆๆธใๅๅพ
