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).

Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? Attend this Webinar to have these questions answered. Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, notfollowing the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? 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.

Areas Covered in the Session:

• FDA Quality Systems Regulation Requirements/Definitions
  
• MDD Requirements/Definitions
  
• Design History File (DHF)
• Definition
• Typical contents
• DHF and outsourced design/production
• DHF and OEM relationships
• Device Master Record (DMR)
• Definition
• Typical contents
• DMR and outsourced design/production
• DMR and OEM relationships
• Controlling and maintaining DMR
• Device History Record (DHR)
• Definition
• Contents
• Using DHR data for tracking and trending
• DHR and outsourced design/production
• DHR and OEM relationships
• Technical File (TF)
• Definition
• Contents
• TF and outsourced design/production
• TF and OEM relationship
• Design/process changes and DHF, DMR, DHR, and TF

Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:

• Quality Managers/Engineers
  
• Production/Process Managers/Engineers
  
• Manufacturing Managers/Engineers
  
• QA and QC managers, inspectors, supervisors and personnel
  
• Documentation Specialists
  
• Supplier Quality Managers/Engineers
  
• Regulatory Managers/Engineers

Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends;  Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both

Areas Covered In the Session:

• The U.S. FDA's DHF
  
• The EU's MDD and the Technical File / Design Dossier
  
• Design Control vs. a Product 'Snapshot in Time'
  
• DHF "Typical" Contents
  
• TF / DD Expected Contents
  
• Parallel Approaches to Documentation -- Teams
  
• Future Directions
  
• FDA and NB Audit Focus

Who will benefit:

• Senior management in Drugs, Devices, Biologics, Dietary Supplements
  
• QA
  
• RA
  
• R&D
  
• Engineering
  
• Production
  
• Operations
  
• Marketing

Overview: There is confusion between the requirements for Design Verification, Process Validation and Design Validation.

While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.

Areas Covered in the Session:

• Requirements for Design Verification.
  
• What is "successful Design Verification"?
  
• Requirements for Process Validation
  
• What are the inputs to Process Validation from Design?
  
• What are the requirements for Design Validation?
  
• Where do I get "production products" for Design Validation?
  
• What is the impact of Design Change during Design Verification? Process Validation? Design Validation?

Who Will Benefit:

• Design Engineers and Managers
  
• Project Managers
  
• Quality Engineers and Managers
  
• Process Engineers and Managers
  
• Regulatory Affairs

Overview: The majority of medical 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 major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Areas Covered in the Session:

• U.S. FDA device clearance / approval
  
• FDA's and EU's emphasis
  
• Product changes and filing a new 510(k) – who's responsible
  
• Tracking and evaluating changes – the "tipping point"
  
• Is the process "risk based"?
  
• K-97-1 and the FDA's "Decision Tree"
  
• Documenting the process / rationale
  
• Resolving a "wrong decision"

Who Will Benefit:

• Senior management, project leaders, internal / external consultants
  
• Regulatory affairs
  
• Quality systems personnel / QAE
  
• R&D and engineering staff
  
• Personnel involved in Lean and Six Sigma Initiatives
  
• New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
  
• CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.

Overview: FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.

Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and practical recommendations on how to respond to FDA's new enforcement practice.

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. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.

Areas Covered in the Session:

• When to submit a 510(k) for a new or modified product
• Types of 510(k) submissions and when to use each
• What is the submission process
• What is contained in a 510(k) submission package
• How to know whether clinical data is required
• How is the submission package assembled
• User fees and 510(k) submissions
• How to interact with the FDA and the reviewer

Who Will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:

• Executive Management
• Regulatory Management
• Professionals involved with premarket notification to the FDA
• R&D personnel involved in approving the design of medical devices
• Sales personnel involved in approving the marketing of medical devices

Overview: The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.

The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. The CDRH director recently retired under a cloud of complaints from center scientists about device approvals being too friendly to manufacturers. More inspectors are taking to the field to attack the backlog of inspections, and FDA is once again pushing third party inspections as another strategy to reduce backlog. The commissioner is speaking about returning to the mission of the agency, protecting the public health, All of these changes bring uncertainty to device approvals and the ability of manufacturers to keep products on the market.

Areas Covered in the seminar:

• The "new" FDA organization and mission
  
• Enforcement changes- increased inspection
  
• Enforcement Changes-new expectations
  
• Manufacturers responsibilities for FDA-483s
  
• Manufacturers responsibilities in Warning Letter situations
  
• Pre-market changes-Human Factors
  
• New Risk Management Guidance

Who Will Benefit:

• Regulatory Managers
  
• Quality Managers
  
• Product Managers
  
• Project Managers

Overview: This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.

The U.S. FDA has stated that the use of a medical device 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 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA.  These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.

Overview: After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still

No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products. The ability for your organization to provide objective evidence that you not only have met the Design Control requirements or regulation but that you can also provide the documentation required is imperative when subjected to investigation or audit activity, whether internal or external in nature. Whether using a large file cabinet full of paper or an electronic documentation system such as a Product Lifecycle Management System, this presentation entitled: “Design History Files: Their Content and Control” will provide you with an insight as to what you need in your Design History File (DHF).

In a regulated industry such as Medical Devices the FDA requires compliance to 21 CFR Part 820.30: Design Controls, while maintaining certification to the ISO9001 and ISO13485 requirements for Product Realization these standards also has similar requirements. During this one hour webinar the presenter will review what needs to be in your design history file, such as design input documents, design review documents, design output documents and design change documentation. Also what should not be in your design history file such as Complaints or Corrective and Preventive Action (CAPA) activity associated with a particular product. Further details regarding the associated documents related to the Complaint or CAPA activities will be included in this presentation. Additionally the presenter will discuss where Operational Documents fit into the Design History File.

The European Union’s Medical Device Directive (MDD) 93/42/EEC Technical file requirements for Medical Devices have similar content to the FDA and ISO13485 Design History File requirements. The presenter will discuss how these documents differ and where the overlaps take place. From Design Concept to Product Obsolescence, the Design History File must be a “living document” with “File” not necessarily meaning that this information be housed all in the same place. The FDA Quality System Regulation requirements for Device Master Record requirements will also be discussed as this has significant impact on your DHF content.

Areas Covered in the Session:

• Basic Overview Of 21 CFR Part 820.30 Design Control Requirements
  
• Concentration on Design History Files Including:
  
• What Needs to be in the DHF
• What Should Not Be in The DHF
• How Operational Documentation Fit in the DHF
• Making your DHF Auditable
• Relationship to the Technical File Requirement of the MDD

Who Will Benefit:

• Design Engineers
• Quality Assurance Personnel
• Program Managers
• Manufacturing Engineers
• Regulatory Personnel
• Engineering Managers

Overview: This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.

This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Why Should You Attend: Negative customer feedback about a medical 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.

Areas Covered in the Session:

• FDA and ISO requirements for complaint handling
  
• Establishment of complaint handling program
  
• What constitutes a complaint
  
• ISO-specific implications of complaint handling
  
• The roles of investigation and corrective action in complaint handling
  
• Complaint trending and reporting
  
• Application of risk management to complaint handling program

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Regulatory management
  
• QA management
  
• Customer Service personnel
  
• Sales personnel
  
• Consultants
  
• Quality system auditors