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: 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 in 2007/2009, 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.

Areas Covered in the Session:

• FDA's current inspection and enforcement practices
  
• FDA's new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
  
• Learning from FDA inspection reports
  
• Part 11 and the new EU Annex 11: similarity and differences
  
• Strategy for cost-effective implementation of the 'new' Part 11:A six step plan
  
• Recommended changes to existing Part 11 programs to reduce costs
  
• Justification and documentation for the FDA and your management
  
• 15 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
  
• How to prepare for Part 11 Inspections

Who Will Benefit:

• IT managers and System Administrators
  
• QA Managers and Personnel
  
• Analysts and Lab Managers
  
• Validation Groups
  
• Software Developers
  
• Validation Professionals
  
• Training Departments
  
• Documentation Department
  
• Consultants

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 is designed for people involved in document preparation and maintenance, and those who have involvement 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, explain and clarify the different records. 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.

Why should you attend: Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following 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?

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 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