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FL: Live Webinar Construct and Manage the Technical File and Design Dossie Live Webinar Construct and Manage the Technical File and Design Dossier
Description
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the glo Date Posted: 30-Apr-18
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Houston: Auditing the Risk Management File - By Dan O Leary DESCRIPTION
Medical device manufacturers must implement risk management systems for their devices. This can be a complicated system requiring a lot of work and multiple resources. If it is not correct, the regulatory authorities may require correc Date Posted: 02-Feb-16
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FL: Live Webinar Use / Human Factors Engineering to Satisfy the New IEC 62 Live Webinar Use / Human Factors Engineering to Satisfy the New IEC 62366-1, -2
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IEC has released a new medical device usability standard, IEC 62366-1:2015 -- Part 1: “Application of the new Usability Engineering Standard to Medic Date Posted: 30-Apr-18
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FL: Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485 Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485
Description
The FDA CGMPs (21 CFR 820.30) and ISO QMS’ (ISO 13485:2016 7.3) expect companies to perform meaningful, results driven Design Control act Date Posted: 27-Apr-18
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FL: Live Webinar Corrective and Preventive Action (CAPA) - Principles of L Live Webinar Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
Description
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements a Date Posted: 08-May-18
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FL: Conducting a life sciences documentation and training gap analysis Conducting a life sciences documentation and training gap analysis
Description
The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and Date Posted: 27-Apr-18
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Houston: Introduction to Risk Management: Medical Devices DESCRIPTION
This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing p Date Posted: 18-Apr-16
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FL: Conducting a life sciences documentation and training gap analysis Conducting a life sciences documentation and training gap analysis
Description
The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and operational requirements, Date Posted: 29-May-18
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Houston: US EU and Japan GMP Requirements: Practical ICH Area Differences DESCRIPTION
This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.
Why Sho Date Posted: 18-Apr-16
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FL: Live Webinar Understanding and Implementing a Quality by Design Progra Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, Date Posted: 26-Apr-18
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FL: Live Webinar Understanding and Implementing a Quality by Design Progra Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, Date Posted: 26-Apr-18
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FL: Live Webinar Understanding and Implementing a Quality by Design Progra Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, Date Posted: 26-Apr-18
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Houston: FDA vs Health Canada: Similarities and Differences by FDA Expert DESCRIPTION
Successful interaction with regulatory agencies can mean the difference between product license approvals and rejections; the difference between successful and unsuccessful PAI and routine inspections. Not all regulatory bodies are cr Date Posted: 15-Apr-16
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Houston: Implementing a Change Control Quality System Successfully DESCRIPTION
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking s Date Posted: 15-Apr-16
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