Best Selling Medical Devices webinars

Module1:Medical Devices in the EU: CE Mark and 93/42/EEC Directive

Areas Covered in the seminar:

• Identify the steps required to obtain CE Mark…and meeting compliance expectations.
• Understand how to apply and use the Conformity Assessment Procedure.
• How to classify your medical device correctly?
• Learn how to use the Technical File correctly.
• How to apply the Declaration of Conformity and why this is critical for success?
• How ISO 13485 fits in with this process as a device company?
• Learn and understand the expectations for the Essential Requirements and the Certification Process
• How is the Authorized Representative involved and why…and the ramifications of not meeting the requirements for CE Mark and 93/42/EEC for your company.

Who will benefit:

This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC. The employees who will benefit include:

• All levels of Management for all departments
• QA/QC/Compliance/Regulatory Affairs
• Marketing & Sales
• Engineering/Technical Services
• Consultants
• Operations and Manufacturing

Instructor Profile:

David R. Dills,, is Senior Consultant with PAREXEL Consulting .Prior to joining the consultancy Mr. Dills has provided independent consulting on technical and regulatory compliance to pharmaceutical, Class I, II, and III, medical device, and biotechnology companies with an emphasis on establishing sustainable compliance and validation environments. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the FDA-regulated industry for more than nineteen years in the areas of Quality Assurance, Quality Engineering, Validation, Regulatory Affairs/Compliance, and Corporate/Operations Management and employed on behalf of well-known, globally recognized manufacturers and service providers.

Mr. Dills areas of expertise include, but not limited to, deploying and implementing validation programs, supplier/vendor qualification, Quality Systems, Validation and other customized training, auditing, QMS policy and procedure development/implementation from cradle to grave, project management, risk management/assessment/risk-based tools and techniques, ISO 9001/13485/14971, MDD 93/42/EEC, conducting Gap Assessments and defining Remediation/CAP activities, Computer and Software Validation/IT Network, Part 11, change control, use of quality and statistical tools and techniques, design controls, CAPA, all aspects of regulatory submissions for Agency approval from authoring to review, and working with international groups/regulations, FDA Mock and PAI Inspections, PDMA/sample accountability, and other related functions and tasks.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published numerous validation and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Module2:The Use and Mis-use of FMEA in Medical Device Risk Management

Areas Covered in the seminar:

• How should I use FMEA in performing risk management?
• What are the problems with FMEA in risk management?
• How should detectability be used in FMEA?
• Is there a role for RPN (Risk Priority Number)?
• Are there other tools to use in conjunction with FMEA?
• Are there FMEA applications in production as well as design?

Who Will Benefit:

This webinar will inform personnel at medical device companies on how to properly use Failure Modes and Effects Analysis (FEMA) in performing risk management.

• Product design teams and personnel assigned to use FMEA at medical device companies
• Quality managers responsible for integrating risk management into quality systems
• Regulatory and compliance personnel who develop premarket filings and technical files for medical devices
• Personnel responsible for verification and validation activities
• Quality system auditors

Instructor Profile:

Edwin L Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.

Module3:Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

Areas Covered in the seminar:

• Verification or Validation -- Recent regulatory expectations
• The Master Validation Plan
• Product Validation - how it differs from process/equipment V&V
• Process/Equipment/Facility Validation
• When and How to use DQ, IQ, OQ, PQ
• How to use your Risk Management Tools (per ISO 14971)
• The 11 "must have" elements of software validaiton
• "White box" and/or "black box" and some test case suggestions.

Who Will Benefit:

• Senior Management
• Project Leaders
• Regulatory Affairs
• Quality Systems Personnel
• R&D and Engineering Staff
• All charged with new product development, regulatory submissions, initiating/overseeing company-wide V&V planning, using a risk-justified approach
• CAPA and P&PC personnel desiring to minimize post-production/life cycle and other costly problems.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association), and publishs a newletter. He is a graduate of UCLA.

Module4:Root Cause Analysis and Tools:

Areas Covered in the seminar:

• Developing and using the Investigation Template.
• 4 basic steps to problem solving.
• 7 basic and simple tools - powerful tools.
• Tools for investigation.
• Tools for problem solving.
• Validate.
• Monitor.
• After the "real" root cause(s) is identified - Now what?
• When to "jump out of the process"?

Who will benefit:

• Management at all levels.
• Project Leaders.
• Regulatory Affairs.
• Quality Systems Personnel.
• R&D and Engineering Staff.
• All charged with new product development, risk analysis / management, regulatory submissions, initiating / overseeing company-wide training, production, validation, and complaint handling.
• Identified staff, operations and line personnel who desire to assume "train-the-trainer" roles to train teams in problem / OOS reduction.

Instructor Profile:

John E. Lincoln, Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.

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