Device Web-based Seminars

MOC 5117 - Installing, Configuring, Troubleshooting, and Maintaining Windows Vista ... of desktop operating system, desktop application, mobile device, networking, and hardware support issues. As working professionals, students must combine technical expertise, problem solving and decision-making skills, and a deep understanding of their business and technical environments to quickly resolve support issues. They consider all variables, justify resolutions with a logical  more...

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel ...device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process  more...

The 510k Submission Requirements Contents and Options - Webinar GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers ...devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing of the medical device.  more...

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Changes in the EU Medical Device Directives 2010 Modifications and the 2012 Recast of the MDD Directives -Changes in the EU Medi This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Master Production Record Requirement - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Price  more...

Design History File DHF the Device Master Record DMR and the Device History Record DHR Principles on Lean Documents and Lean Co Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities. Tuesday, October 25, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

The Investigational Device Exemption When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel We will discuss the situation of the "sponsor/ investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that  more...

Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...

The 510k Process Risk Management - By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process and Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

Designing Drafting Writing and Implementing The Quality Manual ...re how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance requirements without question. As mentioned above, it can be viewed as a  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for routing, managing, approving and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and archiving. The U. S. FDA has eliminated it's "selective enforcement" policy and is looking for proper  more...

Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...nd E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one hour  more...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".  more...

Device Master Record Device History Record BY GCP The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device.  more...

This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products-GCP This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements by GCP Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices  more...

Surviving a DEA Inspection by a Hospice Program BY GCP The Drug Enforcement Administration (DEA) has been focusing on the prescribing of Schedules II narcotic substances by practitioners caring for their patients in a certified Hospice Program where narcotic drugs are prescribed for the individual patient.  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

Pharmaceutical and Biologics Facility Design FDA and Regulatory Aspects by gcp This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect.  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel ...Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also formulates a corresponding  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration - by GlobalCompliancePanel ...Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also formulates a corresponding  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel ...resentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the  more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the  more...

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel his live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances.  more...

Water System Design Start-Up and Validation - Webinar By GlobalCompliancePanel This webinar provides a thorough examination of water systems. We will explore the typical components used in water systems and how these components are combined to achieve intended water quality specifications  more...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...ing during the conduct of clinical research with drugs or devices utilizing human subjects. See why AEa ™s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/ his charge. Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of GCP are important to both  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...ebinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical,  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ould You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...ry agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ... warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors. Areas Covered in the Session: * Complaint  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel ...the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices - Application of Risk Management to Medical Devices, all facets of  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...alidate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this process has successfully prepared several  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...the confusion in the pharmaceutical, Biotech, and Medical device organizations as to what a Standard operating procedure is, and what a Work Instruction is. Areas Covered In the Session: * How to write a work instruction * How to write a standard operating procedure * Properties of an effective work instruction * Properties of an effective Standard operating procedure  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...vement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define,  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ve valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...es are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records regulations;  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of Batch Production Records (BPR), and clearly describe the difference between the master and the  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...nd Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important. Areas Covered in the Session: * What doe the FDA look at when Auditing/ Inspecting a study? * The Sponsor's  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...agement system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...he concept of a Quality System was imposed on the medical device industry through the implementation of a regulation - the Quality System Regulation (QSR), 21CFR820, in 1996. It is not clear when and how the FDA will begin to support its expectation for a Pharmaceutical Quality System through the inspectional process. It is clear that pharmaceutical companies should be proactively considering  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...he compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach. This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF,  more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina ...onal guidance, or framework. It is illegal to market a device for the purpose that it has not been approved for by the FDA. This webinar provides guidelines set by the FDA for off-label promotion. Areas Covered In the Seminar: * Off-label statute * Label claims * Allowable reprints * Promotional compliance * FDCA: The law Who will benefit: * Sales  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ... Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for certification reviews and testing, the product should move through the process quickly and efficiently. We will especially look at  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ould attend: One of the major requirements of the medical device risk management standard ISO 14971 is to develop a Risk Management Plan. One of the least understood and executed requirements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will become a greater issue. The Risk Management Plan establishes  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...tations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...idation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the dependence upon in-process and  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...ly acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed Rule  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and emerging  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...ttend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want. We explain the built in Validation tools  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices. Why should you attend: Any  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ... rationale. Areas Covered in the Session: * FDA Device Clearance / Changes in Direction * Product Changes and Filing a New 510(k) Responsibilities * Tracking / Evaluating Changes and the "Tipping Point" * "Risk-Based" * FDA's K97-1 and "Decision Tree" Model / Matrix * Resolving a "Wrong" Decision Who Will Benefit: * Senior management in Devices and  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...rrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ... as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you  more...

Webinar on Pharmacovigilance Audit - Webinar by GlobalCompliancePanel This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...ion Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...rview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...s between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel .... These practices apply to all pharmaceutical and medical device manufacturing, and their support areas. GDP describes the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel ... as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ... FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The  more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...bmitter regarding the safety and/ or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to  more...

Regulatory Complaint Handling MDRs Recalls - Webinar by GlobalCompliancePanel ...device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ...device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ...device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ...st common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...rm 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed to implement an effective and efficient CA/ PA process. This presentation will begin by defining risk in compliance and the methods, which  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...ailable guidance documents. The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations. ISO 10012: 2003 Measurement management systems - Requirements for measurement processes and measuring equipment, a document in the ISO 9000  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements ...device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products that emit  more...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel ...ers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the selection of  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel ...device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and  more...

Defining Architecting and Managing Risk Assessments - Complinace Webinar by GlobalCompliancePanel Risk Assessments are a vital tool in the Risk and Compliance management arsenal. Unless a business knows at any given time what its exposures are, and how they are evolving, the mitigation steps to manage its risks can never be in lockstep with prevailing circumstances or conditions. Concise Risk Assessments are a vital component of any successful Risk based initiative. Intelligent enquiry is  more...

Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel The Learning Objectives of this presentation include: * Recognize regulatory (FDA/ EU) requirements for batch records and batch record review * Modeling best practices of a technical review of batch records * Discover the essentials of batch record reviewer qualifications and training * Acquire confidence in determining the final decision or recommendations. * Establish  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these  more...

Conduct Your Own Risk Assessments Following ISO Standard 3100031010 It is essential for any organization to first determine its risk appetite and then to conduct its own self assessment as to its actual risk exposure. The new ISO risk standards provide a straight forward method that is suitable for larger and smaller organizations alike. Aligning your risk appetite with your actual risk exposure can help rationalize and prioritize key business opportunity  more...

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel ... we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give practical information  more...

Update on Unique Device Identifier for Device Manufacturers ...device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely into two categories: labeling and tracking. How  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems GlobalCompliancePanel brings a new webinar on the topic of Internal 21CFR Part 11 Compliance Auditing of Computer Systems. Webinar will be on March 11, 2010. Webinar will be presented by Richard Poser. Mr. Poser is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device  more...

New Requirements for the Medical Device Directive MDD ... webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in  more...

Validating Radiation Sterilization for medical device industries GlobalCompliancePanel brings a new webinar on the topic of Validating Radiation Sterilization for medical device industries. Webinar will be on March 9, 2010. Webinar will be presented by Mark Roberts. Mr. Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the  more...

FDA Compliant HPLC Qualification and Performance Testing GlobalCompliancePanel brings a new webinar on the topic of FDA Compliant HPLC Qualification and Performance Testing. Webinar will be on March 4, 2010. Webinar will be presented by Dr. Ludwig Huber. Mr. Huber is Director of Lab compliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Lab compliance, the global on-line resource for validation and  more...

Setting Up and Running a Tougher Supplier Audit Program GlobalCompliancePanel brings a new webinar on the topic of Setting Up and Running a Tougher Supplier Audit Program. Webinar will be on March 2, 2010. Webinar will be presented by John E Lincoln. Mr. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U. S. FDA responses.  more...