25 training found
ComplianceOnline Training
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Medical Device Compliance Training
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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 ...
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Clinical Regulatory Compliance Training
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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 ...
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FDA Regulatory Compliance
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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 ...
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FDA Inspection Primer - Comprehensive Training Course Package (5 Courses)
This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters. Are you sure you're prepared for an FDA inspection in the new future? Do you think your personnel have received enough training to properly get through an FDA inspection? To help FDA regulated companies prepare for agency inspections, we have created a ...
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HR
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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 ...
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Trade and Logistics
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Implementing Robust Supply Chains
This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines. Implementing Robust Supply chains for life-sciences companies are important now and growing in importance as device manufacturers outsource products and services low cost destinations it is becoming longer, more diverse, and more difficult to ...
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Pharmaceuticals
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Product Stability Program - from Drug Development, Clinical Trial and in to Market : Comprehensive Course (4 Modules)
The main purpose of stability program is to evaluate a shelf life for a product to enter a market and before that determine a safe stability profile during clinical trial. There are many guidance which showcase the best practices how to achieve a successful stability program and then specific guidelines are formulated for a particular product ex – ICH regulatory guidance, QBD, PQS, ...
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Good Manufacturing Practices for Pharma Companies - Comprehensive Course ( 8 Modules)
This Pharma GMP courseware covers all aspects of good manufacturing practices starting from difference between GLP and GMP, vendor selection, supplier agreements & management, raw material risk management, HVAC, GMP environmental control, pharma compressed air, annual product reviews ,deviation investigations, human error reduction ...
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Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)
This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in ...
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FDA Compliant Marketing/Promotions for Pharmaceutical Companies - Best Selling Package Webinar
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Pharmaceutical industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc. ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training ...Medical Devices
Product Approval, Promotions & post marketing surveillance for Medical Device Companies - Best Selling Package Webinar
ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training resource for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready to face any kind of compliance challenge and overcome it through expert advice and best ...
EU Medical Device Regulations - Comprehensive Compliance Training Course
Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification on commercializing products. This pack of 5 best-selling ...
Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package
The following is a pack of 5 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and maintenance. In today's complex regulatory environment, medical device manufacturers often find that the road to compliance can be filled with unseen perils that can lead to warning letters ...
Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)
This Medical Device Software Development & Management package training will have 4 courses which covers FDA's Medical Device Software Regulation, Medical Device Software Verification and Validation, IQ / OQ / PQ Approach and IEC ...
Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (5 Courses)
This comprehensive training package is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing regulations. This comprehensive training package is aimed at helping medical device companies ensure that their As manufacturing becomes increasingly global, with responsibility for various parts of the final product vesting with multiple parties, regulatory compliance can be ...
Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 ...
Best Selling Medical Devices webinars
This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies ...Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers
This pack of 2 courses contains the essentials of FDA Medical Device regulations. In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This 3-hour course pack will give an overview of all the major ...
FDA Compliant Marketing/Promotions for Medical Device Companies - Best Selling Package Webinar
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc. ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training ...
EU Medical Device Regulations - Comprehensive Compliance Training Course
The following is a pack of 3 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO ...From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package
The following is a pack of 8 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and ...
Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)
This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®. Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability. These four webinar recording CDs cover not just the IEC 62304 requirements for medical ...
Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)
This comprehensive training package of 8 courses is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing ...
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 ...
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 ...