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« Friday October 29, 2010 »
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An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 - Webinar By ComplianceOnline Start: 10/29/2010 9:00 am End: 10/29/2010 10:15 am This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process. Areas Covered in the Seminar: How are risk management activities integrated throughout the development process. The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process. How to control and verify risk mitigations. How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards. The importance of maintaing Risk Management documents in the Post Production era. What information to include in the Risk Management Plan and Report for better auditability. Who Will Benefit: This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include: Systems engineers responsible for developing requirements Software developers Test Engineers Quality System auditors Engineering managers and personnel Regulatory Affairs Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations - Webinar By ComplianceOnline Start: 10/29/2010 10:00 am End: 10/29/2010 11:00 am This contamination control webinar will discuss how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical and how it can be addressed in developing a successful contamination control program. Areas Covered in the Seminar: Developing effective ways to address spore excursions. Troubleshooting real world experiences. Developing preventative action plans. Learn ways to improve facility design and maintenance. The most effective sporicidal chemistries will be discussed in detail. Cleaning and Disinfection Methods will be addressed. Warning Letters and 483’s from FDA will be discussed and addressed. Who Will Benefit: QA and QC Managers Disinfectant Validation Managers Operations Managers Cleanroom Managers Personnel and contractors that clean and disinfect cleanrooms Regulatory Compliance Managers & Environmental Monitoring Managers Production Managers Cleanroom Operators Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES - Webinar By ComplianceOnline Start: 10/29/2010 10:00 am End: 10/29/2010 11:00 am This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes. Areas Covered in the Seminar: Important factors to know in order to use Comparability Protocols: What are Comparability Protocols? What are the benefits of using Comparability Protocols? When might a Comparability Protocol be useful for a CMC Change? What about pre-approval changes? When might a Comparability Protocol be inappropriate to use? How should a Comparability Protocol be submitted? What happens after submission? What are the basic elements of a Comparability Protocol? How much Risk Potential can be reduced by using a Comparability Protocol? New and expanded uses for Comparability Protocols. For More Details : http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701315?channel=webcentral Contact Number: 650-620-3915 Email: admin@complianceonline.com Key Considerations in Verification & Validation of Medical Devices - Webinar By ComplianceOnline Start: 10/29/2010 10:00 am End: 10/29/2010 11:00 am This Verification & Validation training for medical device will dissect some of the FDA 483 observations related to design verification and design validation and teach you how they can be prevented. Areas Covered in the Seminar: How to properly plan Verification and Validation activities. Verification & Validation testing throughout the product life cycle. How to determine sample sizes needed for testing. What is appropriate objective evidence. How to perform regression analysis. What is meant by Production Equivalence. How do we validate test methods. Special considerations for software based products. Who Will Benefit: This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include: Systems engineers responsible for developing requirements Software developers Test Engineers Quality System auditors Engineering managers and personnel