Top 10 Medical Device Regulations Training (10 Courses)

The medical device industry is facing increasing scrutiny from regulators and existing rules are being updated frequently. It is therefore imperative for device industry professionals to ensure their operations and processes are in compliance, in order to avoid penalties and worse. But what are the regulatory requirements that prove to be a compliance minefield and what are the best practices to avoid violating these?

This package of ten webinar recording CDs covers those issues that can be the biggest regulatory headaches for the medical device industry. Topics covered include: mobile medical applications for devices; updating design history files of older products; risk management of raw materials; quality management system (QMS) competence and training; Excel spreadsheet validation; post market surveillance; regulatory requirements in Latin America; EU directives and CE marking; software verification and validation; and FDA medical device regulations for the beginner.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

Module 1: Mobile Medical Applications for Devices: Trends, Bills and Guidance
Module 2: Updating Compliance for Design History Files of Older Products
Module 3: Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Module 4: (QMS) Competence and Training Requirements per FDA QSR and ISO 13485
Module 5: Validation and Use of Excel® Spreadsheets in Regulated Environments
Module 6: Post Market Surveillance for Medical Devices
Module 7: Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry
Module 8: Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
Module 9: Verification and Validation (V&V) of Software in the Medical Devices
Module 10: FDA Medical Device Regulation for the Beginner

Who will Benefit?

These webinar recording CDs will be beneficial to all professionals working in the medical device industry, but specially:

• Quality Managers
• Regulatory Affairs Managers
• Risk Managers
• Design Control Managers
• Software developers and managers

Webinars Iincluded in the Package:

Module 1 : Mobile Medical Applications for Devices: Trends, Bills and Guidance (Duration: 90 minutes)

This compliance training webinar will explain the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.

Areas Covered in the Webinar:

• Overview of Health IT and mobile industry.
• Basic of mobile applications for health.
• Medical devices related to mobile health.
• Draft guidances in mobile medical apps(FDA 2011).
• FDA Safety & Innovation Act confirms role in mobile field.
• Patient and Consumer health information and security.
• Coming FDA final guidelines and DHHS actions.
• Mobile health standards.
• Mobile Health globally(WHO).

About the Instructor:

Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Information Advisor, Author & Strategist. Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT business development, eHealth education and social media, Health Information policy analysis. He is certified on EHR/PHR, Business Architecture, Clinical Trials, Biotech/Drug Development, and trained in FDA laws and regulations for different products(devices, foods, drugs).

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Module 2 : Updating Compliance for Design History Files of Older Products (60 Minutes)

This webinar will provide a step-by-step procedure to all medical device companies that need to bring their product design history files up to date with current standards.

Areas Covered in the Webinar:

• Multi-functional team approach/responsibility.
• Set procedures and template to complete remediation for design history file of old products to meet current standards.
• Gap analysis.
• Gathering of data to build the design history files.
• Risk procedure.
• Risk assessment for prioritizing remediation.
• Traceability matrix.
• Validations.
• Dealing with the FDA.
• Check list.

About the Instructor:

Rob Braido, is the founder and principle of Visionary Consulting LLC, a consulting firm that specializes in gap analysis and due diligence for management evaluation of product design and emerging technology acquisition. Visionary Consulting also specializes in the project management of validated processes and equipment for product transfers in the medical device and surgical instrument market.

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Module 3 : Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues (60 minutes)

This webinar will explain the current requirements for raw material management with tips about practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Areas Covered in the Webinar:

• FDA requirements for raw material management at GMP facilities
• Common risk management practices
• Vendor selection and validation requirements
• Product specific raw material issues: chemical, biologic and botanical raw materials
• Suggested quality control measures
• FDA’s common findings and possible resolutions
• Trends in FDA inspection of raw material processes
• Regional and multinational raw material providers
• Raw material risk management in the global setting

About the Instructor:

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products.

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Module 4 : (QMS) Competence and Training Requirements per FDA QSR and ISO 13485 (90 minutes)

This webinar will provide detailed information on the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

Areas Covered in the Webinar:

• Understanding the four dimensions of competency
• The regulatory requirements
• Developing the job description
• Conducting the employee gap analysis
• Training
• Special competencies

About the Instructor:

Dan O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. He has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

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Module 5 : Validation and Use of Excel® Spreadsheets in Regulated Environments (90 minutes)

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Areas Covered in the Webinar:

• FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
• How to design spreadsheets for part 11/GxP/SOS/HIPAA compliance.
• Validation during design, development, installation and on-going use.
• When, what and how much to test?
• Dealing standard Excel functions: Recommendations from GAMP® 5.
• How to ensure and validate spreadsheet integrity for GxP and part 11?
• How to apply risk based validation to spreadsheet applications.
• Validation of 'ad hoc' spreadsheet applications.
• How to ensure spreadsheet security and integrity for Part 11 and EU Annex 11.
• How to document planning, specifications, installation, testing and changes.

About the Instructor:

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

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Module 6 : Post Market Surveillance for Medical Devices (90 minutes)

This webinar will explain all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.

Areas Covered in the Webinar:

• The Structure of Post Market Surveillance
• US System
• Complaints (QSR)
• Medical Device Reports
• Corrections and Removals
• International Systems
• Complaints (ISO 13485)
• EU Vigilance
• EU FSCA and FSN
• Canada Adverse Event Reporting
• Post Production Information Collection
• Risk Management (ISO 14971)
• Clinical Evaluation (MDD Annex X)

About the Instructor:

Dan O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. He has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

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Module 7 : Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry (180 minutes)

This 3-hr Latin America Regulatory compliance requirements training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Areas Covered in the Webinar:

• Glossary of Terms.
• Defining the Opportunity.
• Country Facts: Argentina, Brazil, Mexico.
• Latin America's Regulatory Structure for the Life Science Product Industries
• Mercosur - Southern Common Market.
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
• Registration / Required Country Licenses.
• Common Fees.
• Overview of the Rules Governing Medicinal Products & Medical Devices.
• Marketing Authorization Processes - Filings & Registrations.
• Drug Master File (DMF) Use in Latin America Registrations.
• Use of Expert Reports.
• Processing Variations on Licensed Products.
• Labeling & Packaging Leaflet Requirements.
• Orphan Drugs / Rare Diseases.
• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
• How and When to Influence the Regulatory Process.
• The Regulatory Negotiation Process.
• How to Use Regulations / Regulatory Contacts to Your Advantage.
• Resources / Helpful Websites.

About the Instructor:

Robert J. Russell, is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. He has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

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Module 8 : Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs (90 minutes)

This Medical device training will be discussing 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.

Areas Covered in the Webinar:

• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose of the Medical Device Directives.
• Meeting the New Requirements for Conformity Assessment by Product Type.
• 2010 Directive Changes; Additional Requirements.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products.
• An overview of key areas of the Directive:
• Scope of application and definition
• Essential Requirements
• Medical Device Type & Process Path
• Medical Device Technical File
• Clinical Investigations
• Clinical Evaluations
• Notified Bodies

Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

About the Instructor:

Robert J. Russell, is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. He has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

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Module 9 : Verification and Validation (V&V) of Software in the Medical Devices (90 minutes)

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

Areas Covered in the Webinar:

• FDA Quality System Requirements for software.
• FDA guidelines on Software Verification and Validation.
• Smart software verification methods.
• How to design smart validation tests.
• How to conduct Black box testing and white box testing to perform thorough validation.
• How to conduct diabolic tests and wicked tests to avoid product recalls

About the Instructor:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event.

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Module 10 : FDA Medical Device Regulation for the Beginner (180 minutes)
1 CD Price: $799

This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement.

Areas Covered in the Webinar:

• Organizational Structure.
• Statutory and Regulatory Authority.
• Medical Device Classification System.
• Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval.
• The Process for Bringing a Medical Device to Market in the U.S.
• The Components of a  510(k) Premarket Notification.
• A Manufacturer's Responsibilities.
• User Fees.
• Labeling and Promotion.
• An Introduction to the Quality System Regulation (21 CFR Part 820).
• The Import / Export of Medical Devices.
• Inspections.
• FDA Enforcement Activities.

About the Instructor:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration's review and approval of new drug products.

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