ComplianceOnline training
Top 10 Medical Device Regulations Training (10 Courses)
This comprehensive training package of ten courses is aimed at helping medical device companies gain a thorough understanding of the top 10 regulations that they should comply with.
Clinical Regulatory Compliance Training
21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials
Conducting clinical trials in a rapidly evolving electronic environment presents a unique challenge to the medical device industry where not only quality (GLP/GMP) plays an essential role – but collecting accurate, maintaining viable data (GCP) as part of continuous process improvement (while mitigating risk) is an essential and critical component of the development paradigm. The complexity of medical device trials require adherence to 21 CFR Part 11 and Predicate Rules and must work in concert with 21 CFR 832.40. Additionally, many hybridized trials cross into the arena of Proof of Concept to allocate resources to devices and as well as biosimilars as part of the new of investigational products.Clinical Research
Clinical Trials Monitoring - Comprehensive Training Package (4 Courses)
This comprehensive training package of four courses covers clinical trial monitoring techniques, audit procedures and the setting-up of Data Monitoring Committees (DMCs).
FDA Regulatory Compliance
Webinars Series on Water System Compliance for Consumer Products, Medical Devices, Diagnostics, Pharmaceuticals, and Biologics
This Water system compliance training will give you a comprehensive knowledge about water system compliance with relation to Microbial Quality Problems, Microbial Testing, Endotoxin control, Sanitization, Water system validation. Water can be a major source of microbial contamination in the manufacturing systems for Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. There are many standards proposed by different associations and industry bodies related to different aspects of water system compliance. Some of these are quite dated and may, frankly, contain inaccurate information. Until now with ComplianceOnline, accurate and current information could not be found from a single resource. Companies need to know the most current, accurate information on how to control, monitor, validate, and respond to deviations in their water systems in order to stay in compliance.
HR
Family Care and Medical Leave in California: Comprehensive Training Package (2 Courses)
At the crux of the CFRA and FMLA is the notion that an employee is entitled to take a leave of absence for family care or for a serious health condition without the fear of losing his or her job. Parts I and II of this course will teach you how to successfully navigate the requirements set forth by the CFRA and FMLA.