In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Doc...Anita Anzo
Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT
Duration : 60 Minutes
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Doc...Anita Anzo
Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT
Duration : 60 Minutes
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Proven Process Medical Devices, Design, Development, Testing, and ManufactureMichael Kanis
Medical Device, Diagnostics, Therapeutics, Surgical tools, FDA, QSR, Therapeutics, Implantables, Drug Delivery Pumps, RF Ablation Devices, Project Management, Class 7 clean room, High risk Class II and III devices.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Proven Process Medical Devices, Design, Development, Testing, and ManufactureMichael Kanis
Medical Device, Diagnostics, Therapeutics, Surgical tools, FDA, QSR, Therapeutics, Implantables, Drug Delivery Pumps, RF Ablation Devices, Project Management, Class 7 clean room, High risk Class II and III devices.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
This informative presentation on integration of PLM and ERP comes to you from Barry-Wehmiller International resources (BWIR), global services & solutions partner to SolidWorks Enterprise PDM, This was made at SolidWorks World 2010 in specific context to integration of various ERP systems to Enterprise PDM . This presentation covers:
1. Role of PDM & ERP in Product Lifecycle
2. Need for integration between PDM/PLM and ERP
3. Understanding Industry-specific demands
4. SolidWorks Enterprise PDM and ERP integration
5. Case Study 1 : SolidWorks EPDM – Infor XA Integration
6. Case Study 2 : SolidWorks EPDM – SAP Integration
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
PLM-Seminar at Gardermoen: How the idea of single BoM can fit variant and con...Oleg Shilovitsky
The slides from PLM-seminar at Gardermoen: Product Configuration and Variant Management
http://www.infuseit.com/no/Hovedmeny/Arrangementer/SubPages/Oslo2015/
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
Creating Design History Files (DHF), the Device Master Records (DMR) and the ...Anita Anzo
Scheduled On : Friday, October 18, 2013 at 1:00 PM EDT
Duration: 60 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1042
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Project Management for Computer Systems ValidationAnita Anzo
Scheduled On : Thursday, November 7, 2013 at 12:00 noon
Duration: 120 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050
Webinar on how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211.
Corrective actions current expectation of iso 13458 & fda auditorsOnlineCompliance Panel
Webinar will provide an understanding of current expectations of ISO 13485 notified body auditors regarding containment or correction of nonconformity.
Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
This webinar will help you understand whether the acceptance activities are compliant with 21 CFR 820.80 and 820.86, and QSR and Risk Management activities.
Providing a superior foundation for your corporate quality systemScott Reedy
Quality systems for companies regulated by the FDA must follow current good manufacturing practices (CGMPs) to comply with the FDA's 21 CFR part 820 regulations. This whitepaper discusses how Arena has expanded the traditional borders of QMS to manage product development and quality management processes in a single solution.
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21 cfr part 820 quality system regulation applying principles of lean documents and lean configuration
1. Webinar On 21 CFR Part 820 - Quality System
Regulation - Applying Principles of Lean
Documents and Lean Configuration
Presented By Jose Mora
Contact Us: 416-915-4458
Hosting By
Compliance Trainings
Please visit us at https://compliancetrainings.com
Scheduled On : Friday, April 24, 2015 at 13:00 Hrs
2. Contact Us: 416-915-4458
We Empower, You Comply!
Webinar Description:
21 CFR Part 820 - Quality System Regulation - Applying
Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management
System (QMS) processes in a state of control, via controlled documents and
objective evidence in the form of records. Medical device manufacturing plants,
required to follow 21 CFR Part 820, have the additional responsibility to ensure
that each and every step of the manufacturing process is controlled by work
instructions, SOPs, set-up instructions, equipment maintenance, and support
functions, and that evidence of this work is maintained by controlled records.
Prior to computer systems and databases, managers and quality personnel created
complex visual numbering schemes, cross-referencing methods and complex
filing systems for purposes of retrieval and control. These grew over the years
into the extremely complex and convoluted systems we find today throughout the
life sciences, including the medical device industry.
As is often the case, automation and computers do not always replace the legacy
methods, policies, and rules that were necessary with manual and paper systems
but are now obsolete.
Product Id MD1482
Category Medical Devices
Scheduled On Friday, April 24, 2015 at 13:00 Hrs
Duration 90 Minutes
Speaker Jose Mora
Login at https://compliancetrainings.com/siteengine/Login.aspx
3. Unfortunately, that is the case in the overwhelming majority of medical device
companies. The benefits of automation and information retrieval systems are
not fully realized due to the legacy policy constraints that still hamper them.
If you are constantly struggling to create, manage, and maintain all of the
information found in controlled documents, all of which are often redundant,
repetitive, and clustered together in an awkward manner, this webinar is
something that will give you a different perspective and a very different approach
that you can use.
If your design and manufacturing resources are spending too much time on
documentation and not enough time on actual design and manufacturing you as
a manager need to be looking for ways to simplify their work.
In this webinar, we apply the Theory of Lean documents and its corollary Theory
of Lean Configuration to present a fresh approach to following 21 CFR Part 820,
yet is based on solid principles and proven practices.
Areas Covered in the Session :
Brief introduction to Lean Documents and Lean Configuration
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to
design control documents
Basic functions found in a life sciences manufacturing plant
Key types of controlled documents and records for manufacturing
Quality Management System (QMS) elements controlled via documentation
Bringing it all together
Who Will Benefit :
All Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Design Assurance
Quality Assurance
Operations
Document Control
Manufacturing Engineering
4. To Register This Webinar Please Visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1482
Contact Us For Immediate Assistance
@ 416-915-4458
or Mail Us At
uttam@compliancetrainings.com
support@compliancetrainings.com
José Mora is a Principal Consultant specializing in Manufacturing Engineering
and Quality Systems. For over 30 years he has worked in the medical device and
life sciences industry specializing in manufacturing, process development,
tooling, and quality systems. Prior to working full time as a consulting partner
for Atzari Consulting, José served as Director of Manufacturing Engineering at
Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where
he introduced process performance, problem solving, and quality system
methodologies. During that time he prepared a white paper on the application of
lean manufacturing methods to the creation and management of controlled
documents and a template for strategic deployment. José led the launch of
manufacturing at a start-up urology products company as Director of
Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator
park in Coralville, IA, creating a world-class medical device manufacturing
operation, with JIT, kanban systems, visual workplace and lean manufacturing
practices.
Speaker Profile