Pack of 11 Comprehensive Training on FDA Rules and Regulations for Medical Devices

This package training program will cite what are the key considerations in medical device design and validation that can help prevent FDA 483s, poor due diligence can lead to issues like recalls or warning letters. Attend this training to understand FDA Expectations for Purchasing Controls, lessons learned from quality issues, developing effective purchasing controls, more. This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices, an overview of Medical Device Registration and Approval Process for the Pacific Rim (including China, Singapore, Taiwan and Hong Kong). A guidebook for knowing the regulatory and compliance requirements in auditing subcontractors for Pharma and Medical Device. Get informed on the next revision of ISO 1385:2006 standards and the changes, requirements that Medical Device Companies has to make. Learn IQ, OQ, PQ methodologies for validating Medical Device Software; learn everything about Quality Management System that is common in Pharma and medical device. Get a thorough knowledge on Complaint Management and Medical Device Reporting in FDA for maintaining public safety. Register for this webcast and Medical Device Companies get trained on software FMEA, its applications to get rid of the failures, mishaps that happen in the Medical Device Design and Development Process. Get trained on the Medical Device Registration and Approval Process for South America.
Instructor: Mercedes Massana, Susanne Manz, John Chapman, David R. Dills, Jan Warner , Mark Swanson , Ms. Chettiar , Dev Raheja,
Product ID: PACK70059

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Systems Engineers responsible for developing requirements
  • Software Developers
  • Test Engineers
  • Quality System Auditors
  • Engineering managers and Personnel
  • Quality or Compliance personnel conducting Due Diligence
  • Business development personnel wanting to understand Quality and Compliance aspects of Due Diligence
  • Integration Teams
  • Individuals new to Medical Device Companies
  • Supplier Quality Engineers
  • Compliance Personnel
  • Regulatory Affairs Managers
  • Manufacturing Engineers
  • Hospital Operating Room Nurse Supervisors
  • CRO's
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Engineering/Technical Services/Operations
  • Consultants
  • Medical device manufacturers
  • Pharmaceutical manufacturers
  • OTC product manufacturers
  • Subcontractors
  • Medical Device Industry
  • Suppliers to medical device manufacturers
  • Systems Engineers
  • Software testers
  • Test Engineers
  • Quality System Auditors
  • Engineering Managers and personnel
  • QA/QC and Regulatory Professionals in pharmaceutical and medical device industries
  • Quality Engineers and Quality Auditors
  • Complaint Specialists and Managers
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Anyone Interested in Medical Device Complaint Handling Systems
  • Software Development Managers and Engineers
  • Hardware Managers and Engineers
  • Quality Assurance Staff
  • Regulatory Affairs Staff
  • Service Engineering Managers and Engineers
  • Medical device and In Vitro Diagnostics manufacturers

Webinars included in the Package:

Key Considerations in Verification & Validation of Medical Devices (Duration: 75 Minutes)

This presentation will cover a requirements management approach consistent with the CMMi Requirements Management KPA, which helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements. We will cover key considerations and best practices when performing design verification and design validation of medical devices. It is intended to give the attendees key knowledge in areas that are repeatedly cited in FDA 483s.

Objectives of the Presentation:

  • What is Verification and Validation
  • What are the major differences between Verification and Validation
  • The relationship between software validation and design validation
  • How to avoid FDA 483s related to verification and validation

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems.

Due Diligence of Quality Systems for Medical Device Companies (Duration: 90 Minutes)

Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster months or even years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly help you avoid that disaster and help you improve your business success.

Objectives of the Presentation:

  • Understand Due Diligence with respect to Quality System requirements
  • Understand the process and expectations for Due Diligence
  • Understand how to conduct a Due Diligence inspection
  • Understand how to document and Report Results
  • Understand what to report to management
  • How to create a meaningful action plan for integration teams

Instructor Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Design Quality, and Director of Corporate Compliance.

Purchasing Controls for Medical Device Companies (Duration: 90 Minutes)

Medical Device manufacturers routinely outsource some or all of their design, manufacturing, or other activities. However, suppliers of components and sub-assemblies are not independently required to comply with the Quality System Regulation (QSR). Therefore, it is imperative that finished goods manufacturers have processes in place to ensure the quality of any purchased products from suppliers.
Additionally, the QSR imposes Purchasing Control Requirements on finished goods manufacturer. Finished goods manufacturers must have a strong system in place to identify, evaluate, and monitor suppliers. They must be able to prioritize and determine the extent of controls required for each suppler.

Objectives of the Presentation:

  • Understand FDA expectations for Purchasing Controls
  • Understand lessons learned from recalls and other major quality issues
  • Steps to developing effective purchasing controls
  • How the FDA will determine cracks in your process
  • How to manage your suppliers
  • Learn what documents the FDA will want to see

Instructor Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Design Quality, and Director of Corporate Compliance.

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements (Duration: 60 Minutes)

Much attention has been paid to the regulatory requirements of reprocessing single use devices. However, there is increasing attention being directed towards reprocessing reusable medical devices and regulatory requirements. If a firm reprocesses another manufacturer's medical device, it becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. Cleaning and sterilization instructions must be precise and validated if intended to be re-sterilized by the user facility.

Objectives of the Presentation:

  • Reasoning behind labeling requirements
  • Intended use and design
  • Regulatory requirements
  • Validating cleaning and sterilization
  • Standards/guidance

Instructor Profile:

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Subcontractor Auditing for Pharma and Medical Device (Duration: 60 Minutes)

Personnel working in the Pharma and Medical Device industries, which use subcontractors to manufacture components and finished products, must attend this webinar to understand the regulatory requirements.

Objectives of the Presentation:

  • What types of subcontractors should be audited
  • Subcontractor audit programs and procedures
  • Regulatory requirements (FDA)
  • Audit process
  • How to write an audit report
  • Follow-up and corrective actions

Instructor Profile:

Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: pharmaceutical, medical device, OTC and personal care, homeopathic drugs, dietary supplements and cosmetics. He is the owner of IQA Consulting Services; a niche provider of quality and compliance services to the FDA and similarly regulated industries. Jan has extensive experience working for Fortune 500 as well as start-up companies.

ISO 13485:2016 - What's Changing and What It Means for Medical Device Companies (Duration: 90 Minutes)

This webinar focuses on the updates related to the general use of the standard and the high level overview of those coming changes. This training is important for Medical Device companies to prepare for those changes and the potential impact they may have on their business.

Objectives of the Presentation:

  • Understand the general use of ISO 13485 standard
  • Understand the reasons driving the changes to ISO 13485 for this third revision
  • Understand what is changing in ISO 13485
  • Understand how these changes affect an organization involved in the medical device industry
  • Be able to use the content to implement the required changes in an organization to obtain or maintain a quality certification
  • Determine other considerations for obtaining or maintaining a certification for an ISO 13485 quality system

Instructor Profile:

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group, a group focussing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. Mark has spent the last three years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 and has also participated with ISO TC176, WG24 on the next version of ISO 9001.

Using an IQ / OQ / PQ Approach to Validating Medical Device Software (Duration: 60 Minutes)

Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software. This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.

Objectives of the Presentation:

  • Development of software test plans
  • How to apply IQ / OQ and PQ techniques to software
  • Risk based software testing
  • How does Software Validation relate to Design Validation?
  • Typical software tests
  • What is the appropriate sample size for software testing?
  • Software issue tracking
  • How to address open issues when releasing software

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella (Duration: 75 Minutes)

Professionals are often thrown into the challenge of adapting and expanding their quality system requirements in order to accommodate their expanding business and customer needs. This webinar will help you overcome the challenge by educating you on the QMS needs that are common and those that are unique to Pharma and Medical device world so you can focus on areas that need to be nurtured as you make this important transition from 21 CFR 210/211 to 21 CFR 820 and vice versa to fulfil FDA regulatory needs for your effective quality system that will be housed under one umbrella.

Objectives of the Presentation:

  • What are the features of QMS that are common to the pharma and medical device QMS?
  • Which features are unique to the world of medical devices for globally marketed products?
  • Which features are unique to the pharmaceutical/drug world?
  • What is required to fulfill the cGMP needs of the fast growing Combination products?
  • How should the gap analysis be performed for a seamless transition?
  • Planning and implementation of your QMS under one umbrella to successfully withstand scrutiny by worldwide regulatory bodies and for your overall business risk management

Instructor Profile:

Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Complaint Handling and Medical Device Reporting (Duration: 90 Minutes)

Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining public safety. Complaints can be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting.

Objectives of the Presentation:

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness

Instructor Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Design Quality, and Director of Corporate Compliance.

Software FMEA for Medical Devices (Duration: 60 Minutes)

Understanding system failures in advance and evidence based best software practices is a profound knowledge. This webinar is conducted by the international risk management consultant with over 30 years experience and the author of the text Preventing Medical Device Recalls.

Objectives of the Presentation:

  • ISO 14971 requirements for FMEA
  • Difference between software FMEA and hardware FMEA
  • How can we apply FMEA to software design?
  • FMEA at several levels of software
  • Predicting software malfunctions and failures
  • Applying risk acceptance criteria
  • Failure avoidance strategies
  • FDA requirements for software design control
  • Role of management in software design

Instructor Profile:

Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems.

Medical Device Registration and Approval Process for South America (Duration: 90 Minutes)

Learn how to register your medical devices and gain approval from the regulatory authorities in Brazil, Argentina and Columbia.Medical devices in Brazil are regulated by the Agencia Nacional de Vigilância Sanitária (ANVISA). Brazil's base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC. Manufacturers without a place of business in Argentina must appoint an in-country representative known as an Argentina Registration Holder (ARH) to submit registration applications and act as liaison with ANMAT. Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country's medical device regulator.

Objectives of the Presentation:

  • Determine the correct classification for your device, and complete all necessary documentation
  • Evaluate technical and scientific data that demonstrates safety and efficacy of your medical device, and provide guidance regarding acceptability of the information for each country
  • Submit an application and legal documents to the regulatory authorities for review and approval
  • Learn what devices require INMETRO Certification in Brazil
  • Manufacturers without a place of business in Argentina must appoint an in-country representative known as an Argentina Registration Holder (ARH) to submit registration applications and act as liaison with ANMAT
  • Understand how to market your medical device in Colombia and the requirements for registration with the National Food and Drug Surveillance Institute (INVIMA), the country's medical device regulator

Instructor Profile:

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Price:$700.00
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