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.

Medical Device Compliance Training

Updating Compliance for Design History Files of Older Products

Many regulated companies have not brought their old products up to current FDA standards and are not in total compliance. This webinar defines the criteria to be used for medical products design history file remediation. For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team. In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

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.

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.