This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
Keeping a finger on the pulse of regulatory changes taking place worldwide is hard to do, but nonetheless imperative. This presentation will provide a high-level overview of the more significant global regulatory changes that will impact orthopaedic manufacturers in the next two years. These include European Medical Device Regulation, ISO 13485:2016, MDSAP and U.S. FDA changes, as well as other global topics of interest. Ms. Loh, who leads the regulatory team at EMERGO, returned to OMTEC to provide perspective on strategies and risks to consider with these wide-ranging and sometimes overlapping matters.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in the New Pharmaceutical Quality Paradigm December 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
Keeping a finger on the pulse of regulatory changes taking place worldwide is hard to do, but nonetheless imperative. This presentation will provide a high-level overview of the more significant global regulatory changes that will impact orthopaedic manufacturers in the next two years. These include European Medical Device Regulation, ISO 13485:2016, MDSAP and U.S. FDA changes, as well as other global topics of interest. Ms. Loh, who leads the regulatory team at EMERGO, returned to OMTEC to provide perspective on strategies and risks to consider with these wide-ranging and sometimes overlapping matters.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in the New Pharmaceutical Quality Paradigm December 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
Presentation: Prescription medicine registration process performanceTGA Australia
The presentation provides an update on the streamlined submission process, five years on, including the evolution of the milestone-based process from inception to the present day, and opportunities for future improvements.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:
the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.
This presentation presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Learning in Interorganizational Relationships of the Union of Clothing Manufa...IJERA Editor
The research presents as a cooperation network can provide a collective learning environment, represented mainly by the dynamics of interaction that occurs between companies through the emergence of interorganizational learning and innovation practices. Thus, this article aims to investigate what the main practices of inter-organizational learning and innovation in existing partner organizations in the Union network of Clothing Manufacturers of Taquaral / Goiás and region (UCMT / GOIÁS), trying to understand how they occur. As a research strategy, we opted for an exploratory research, with qualitative and quantitative approach through case study. In the survey results found that learning companies are contributing to the improvement of production processes and the introduction of new products by companies. It was found that the associated companies had access to new concepts and know-how of production, knowledge providers and representatives, knowledge about new technologies and raw materials, creating their brands and new product designs, as well as a better understanding of business cooperative system. Moreover, the experience of formal and informal situations of inter-organizational learning, which offered chances to UCMT entrepreneurs so that they could share skills, experiences and know-how promoted on the network, an intense sharing tacit knowledge environment, key resource for sustainability of competitive advantages in the long term. Thus, the creation of the Network enabled knowledge to be shared, bringing benefits to members, such as production processes, suppliers, raw materials, technology and market.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
Presentation: Prescription medicine registration process performanceTGA Australia
The presentation provides an update on the streamlined submission process, five years on, including the evolution of the milestone-based process from inception to the present day, and opportunities for future improvements.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:
the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.
This presentation presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Learning in Interorganizational Relationships of the Union of Clothing Manufa...IJERA Editor
The research presents as a cooperation network can provide a collective learning environment, represented mainly by the dynamics of interaction that occurs between companies through the emergence of interorganizational learning and innovation practices. Thus, this article aims to investigate what the main practices of inter-organizational learning and innovation in existing partner organizations in the Union network of Clothing Manufacturers of Taquaral / Goiás and region (UCMT / GOIÁS), trying to understand how they occur. As a research strategy, we opted for an exploratory research, with qualitative and quantitative approach through case study. In the survey results found that learning companies are contributing to the improvement of production processes and the introduction of new products by companies. It was found that the associated companies had access to new concepts and know-how of production, knowledge providers and representatives, knowledge about new technologies and raw materials, creating their brands and new product designs, as well as a better understanding of business cooperative system. Moreover, the experience of formal and informal situations of inter-organizational learning, which offered chances to UCMT entrepreneurs so that they could share skills, experiences and know-how promoted on the network, an intense sharing tacit knowledge environment, key resource for sustainability of competitive advantages in the long term. Thus, the creation of the Network enabled knowledge to be shared, bringing benefits to members, such as production processes, suppliers, raw materials, technology and market.
Design and Materials Selection: analysis of similar sanitary pads for daily useIJERA Editor
Hygiene practices have effects on vulvovaginal microbiota. Specific products for intimate female hygiene are available in the market, such as the sanitary pads. Since these pads were introduced in the market , they became the focus of research that seek to improve their shape, manufacturing processes and the properties of materials used in order to provide more benefits to users. Thus, the present study aimed to characterize the fabrics used in daily sanitary pads, focusing on the development of future products. The spectra generated by FTIR/ATR suggest that the samples were composed of polypropylene. The photomicrographs showed that the polymeric outer layer was made of nonwoven fabric manufactured by spunbond and point bonding processes.
This webinar discusses the handling of state taxes when an employee lives in one state and works in another, or works in two or more states simultaneously. Includes what taxes to be on the lookout for including locals, determining liability as an employer, reciprocal agreements, resident and nonresident taxation, Form W-4 equivalents and state unemployment insurance.For More Details:
Email: david@grcts.com
Tel: +1-248-233-2049
Web: www.grcts.com
عرض لبعض الأفكار المبتكرة في العالم
مع بيان االفرق في كل واحدٍ منها
و أخيراً عرض لبعض حقوق الملكية و تجهيزات المنتجات و تغليفها
و كيفية عرضها و طرق جعلها صالحة لأكثر من إستخدام واحد
A deficiência de ferro e anemia afeta mais de 3,5 bilhões de pessoas ao redor do mundo (Organização Mundial da Saúde), resultando em problemas de saúde e comprometimento cognitivo em todas as fases da vida.
"Um terço da população mundial sofre de anemia e isso tem consequências econômicas graves", disse Sue Horton, professora da Universidade de Toronto em Economia e principal autora do estudo 'The Economics of Iron Deficiency'.
Simulation Model solves exact the Enigma named Generating high Voltages and h...IJERA Editor
Simulation model of Tesla coil has been successfully completed, and has been verified the procedure and functioning. The literature and documentation for the model were taken from the rich sources, especially the copies of Tesla patents. The oscillating system‟s electrical scheme consists of the voltage supply 220/50 Hz, Fe transformer, capacitor and belonging chosen electrical components, the air gap in the primary Tesla coil (air transformer) and spark gap in the exit of the coil. The investigation of the oscillating process Tesla coil‟s system using the simulation model in MATLAB & SIMULINK have given the exact solution the enigma named the generating high voltage and high frequency the Tesla‟s coil. The inductance voltage from the spark current in the primary (coil) with its high voltage impulse excites the oscillating series circuit Ce-L3-R3 on the secondary of the air transformer to its own damped oscillations.
Harmonics Reduction of Multilevel Inverter Drive Using Sine Carrier Pulse Wid...IJERA Editor
The main objective of this paper is to control the speed of an induction motor by using seven level diode clamped multilevel inverter and improve the high quality sinusoidal output voltage with reduced harmonics. The presented scheme for diode clamped multilevel inverter is sine carrier Pulse Width Modulation control. An open loop speed control can be achieved by using V/ƒ method. This method can be implemented by changing the supply voltage and frequency applied to the three phase induction motor at constant ratio. The presented system is an effective replacement for the conventional method which has high switching losses, its result ends in a poor drive performance. The simulation result portrays the effective control in the motor speed and an enhanced drive performance through reduction in total harmonic distortion (THD). The effectiveness of the system is verified through simulation using PSIM6.1 Simulink package
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.
Regulatory Affairs Overview in the Digital Age.pdfSharan Murugan
Regulatory Affairs Overview in the Digital Age
This captivating slide deck provides a comprehensive overview of the various departments within regulatory affairs, illuminates salary prospects, explores emerging trends, and unveils the exciting future that awaits professionals in this dynamic field. Prepare to be captivated by visually engaging slides that offer invaluable insights and equip you to harness the power of the digital revolution in regulatory affairs. Get ready to unlock a world of opportunities for success in the ever-evolving landscape of regulatory affairs.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot ProgramTGA Australia
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arr...marcus evans Network
Paul A. Arrendell, a speaker at the marcus evans Medical Device Manufacturing Summit Spring 2014 and the Medical Device R&D Summit Spring 2014, on building a Culture of Quality.
Interview with: Paul A. Arrendell, Vice President, Global Quality, Kinetic Concepts, Inc.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Similar to Clinical evaluation and the latest 2016 guideline (20)
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Ethnobotany and Ethnopharmacology:
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Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
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2. Clinical Evaluation and the Latest 2016 Guideline
11/18/2016www.grcts.com
2
Description:
This “General Guidance” document promotes a common approach to clinical
evaluation for "medical devices regulated by directives 90/385/EEC and
93/42/EEC. It does not concern in vitro diagnostic devices. The depth and
extent of clinical evaluations should be flexible and appropriate to the nature,
intended purpose, and risks of the device in question. Therefore, this
guidance is not intended to impose device-specific requirements. The Clinical
Evaluation Report (CER) is a living document required for the EU market
for all classes of new and existing devices, detailing the clinical evaluation of a
product throughout its life-cycle.
3. Clinical Evaluation and the Latest 2016 Guideline
11/18/2016www.grcts.com
3
While the requirement to have a CER is not new, it is subject to more intense scrutiny
by Notified Bodies in the conformity assessment phase, and CERs are increasingly
being assessed in the post-market phase. This revised MEDDEV is being generated
within a context of increased scrutiny on the Notified Bodies. The revision of this
document represents a complete re-write of this MEDDEV, with many new
Appendices and much new guidance. The new MEDDEV can be considered more
instructive, but also more prescriptive in particular regarding the use of evidence
from equivalent devices.
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Areas covered in the session:
• Introduction to MEDDEV 2.7.1, Revision 4 (2016)
• This revised MEDDEV is generated within a context of increased
scrutiny on the Notified Bodies (NB) by the Joint Assessments from the
Competent Authorities, which has led to an increase in the level of
review the NB exercise over clinical evaluation
• Frequency for updating the CER is also much more prescriptive now
and you must define and justify the frequency, based on “significant
risk” of the device, as well as how “well-established”
• One of the largest changes in this revision, the demonstration of
“equivalence” is much harder now
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Revision will lead to more clinical investigations, probably of larger size and notified bodies
will be looking more closely at how all the essential requirements are met, including those
with regard to usability
• Manufacturers should start discussing with their notified bodies how they will start
implementing these new requirements and to start performing their gap assessments and
resource needs-assessments now.
• General considerations on updating the clinical evaluation
• How is a clinical evaluation performed?
• Appraisal of pertinent data
• The role of the notified body in the assessment of clinical evaluation reports and key
changes in 2016
• Other changes and revisions of this document and represents a complete re-write of this
MEDDEV, with many new Appendices and much new guidance
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Who will benefit:
This webinar will provide valuable and additional insight and an overview
for the medical device and IVD companies involved in establishing and
maintaining a state of compliance and meeting compliance deadlines for
UDI.
Employees and personnel who will benefit include:
• All levels of management and departmental representatives any anyone
who desire a better understanding or a "refresh" overview of MEDDEV
2.7.1, Revision 4
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Instructor Profile:
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides
regulatory affairs, compliance and quality consultative services for early-stage and
established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical
manufacturers on the global landscape, and also has an accomplished record with more than
25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
He has been previously employed, with increasing responsibilities by medical device
manufacturers and consultancies, including a globally recognized CRO and has worked
directly with manufacturers engaged in compliance remediation activities and services
involving consent decrees, CIA’s, warning letters, 483 observations, and customer
generated compliance events, and prepares for and conducts QS and regulatory audits.
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He has been directly involved with constructing, reviewing, and/ or remediating
regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and
NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely
with the key stakeholders and Agency/Center Reviewers regarding submission
meetings and negotiations; clinical affairs and study submissions; and provides
regulatory submissions and post-market project leadership and guidance covering
different therapeutic and medical specialties based on classification.
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Mr. Dills has a strong background in the interpretation and applicability of FDA regulations,
including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance
requirements, GxP training, leads and directs activities for the registration and approval
process and working with Agencies in Asia Pacific, EU and The Americas, including but not
limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA,
TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation
and remediation strategies in response to inspection findings. Additional activities include Pre-
FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-
approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for
remediation planning and monitoring, and assessment of the critical sub-systems, records and
document controls; and strives for reduction of regulatory compliance risk for companies.
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Directs and leads efforts for PM support and consultative services on behalf of manufacturers
and subcontracted by third-party consultancies and provides services involving all phases of the
product development, submission, and commercialization process from premarketing to
postmarketing; retained as U.S. Agent for international pharma and device clients; conducting
supplier and QS audits/assessments; establishment registration and listing; Agency inspection
readiness preparation and remediation; preparing Agency responses due to enforcement
actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering
support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting,
Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate
Quality Management and documentation systems for GxP compliance; preparation for ISO
13485 registration and CE Mark; and multi-country product registrations and licensing.
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Mr. Dills manages quality, regulatory and compliance projects with
multiple competing priorities having a direct impact on site
operations/commercial opportunities. Develops strategies for
governmental approval to introduce new products to market, provides
guidance and clarity on regulatory requirements, prepares and/or
reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE and BLA],
including design dossiers and technical files, and other applications for
Asia Pacific, The Americas and EU. Directs and leads efforts in
establishing and retooling QA systems with emphasis on preventing the
design, manufacture, and shipment of defective product; provide
compliance engineering support; and lead efforts for GxP Strategic
Compliance.
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Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and
complaints) related to development, manufacturing, and commercialization, and
recommends action to senior leadership to ensure effective resolution for
manufacturers to achieve sustainable and proven compliant systems. Background
encompasses broad capabilities in quality systems; documentation development and
remediation; RA/RC oversight and governance; design controls; CAPA/investigations;
GxP training; software and process validation with compliance oversight; supplier
management; interfaces with FDA and other Agencies on the regulatory landscape;
compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE
Mark requirements; and demonstrates credible experience to optimize business
performance through proactive strategies to mitigate compliance exposure.
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He also develops strategies and adds business value to manufacturers by providing strategic and
tactical solutions that facilitate the achievement of regulatory and quality milestones and on
minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and
Agency Mock Inspections; provides assistance during inspections and with post-inspection
correspondence and meetings, involved in the product life cycle and commercialization process
and works effectively across all functions for overall corporate compliance to support a
company’s goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory
precedents and new legislation; understands the competitive landscape; develops the business and
regulatory approach; conducts persuasive communication with regulatory authorities; executes
an effective path to approval; assists with GxP compliance strategies, effectively coordinates
development in multiple markets; selects appropriate testing and manufacturing suppliers; and
strives for overall corporate compliance with regulations in The Americas, EU, and Asia Pacific.
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He provides direction on understanding the regulatory landscape for the product and
provides a fully integrated approach to device development including design controls,
and effective communications with Regulatory Authorities related to product
development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training
Institute, Editorial Advisory Boards for Software Quality Professional and the
Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance
and Journal of Validation Technology and on the Readers’ Board for Medical Device
& Diagnostic Industry and Medical Product Manufacturing News and was nominated
and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of
Professionals.
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Mr. Dills has authored and published validation, regulatory and compliance-related
articles, commentaries and technical guides, and is an accomplished global industry
presenter. Mr. Dills’ academic degrees include Environmental Science and Biology.
He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the
Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working
groups.
