Conference Presentations

How to Prepare for an FDA Inspection: A Practical Perspective

Russ Davies
Vice President Regulatory Affairs and Quality Systems
Smiths Medical NA

• How to prepare and conduct an FDA inspection

• Case studies – lessons learned and experiences

• What went well and what didn’t

• Site and system preparation

• Staff preparation

• Perspective on inspection in U.S. and outside the U.S.

FDA's Inspection Authority and How to Respond to Troublesome Requests

Donald Segal
Shareholder
Buchanan Ingersoll

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA has broad authority to inspect any facility that manufactures, processes, or holds for introduction into interstate commerce foods, drugs, medical devices, or cosmetics. FDA agents are authorized to enter, without a warrant, any such facility provided that such entry falls within reasonable limits, and is conducted in a reasonable manner. FDA agents are further authorized to inspect all equipment, finished and unfinished materials, containers, and labeling.

FDA may conduct inspections on an unannounced basis or may call ahead. They may inspect on a "for cause" basis or merely because it is the company's time to be inspected. Additionaly FDA may conduct preapproval inspections prior to approving a medical device or drug pursuant to a premarket approval application (PMA) or new drug application (NDA).

This presentation will discuss troublesome issues that typically arise during inspections and will suggest ways to deal with those issues. These suggestions will include for example, how to deal with the inspector during the course of the inspection and how to respond to document requests during the inspection. Additionally, the presentation will address the end-of-inspection Notice of Inspectional Observations (Form 483) and suggestions for preparing an effective response.

Global Medical Devices: What You Need to Know About the CE Mark Directive and Third Party Audit Process

Brad Amundson
Regulatory Compliance Manager
SGS International Certification Services

Bradley S. Amundson is currently employed by SGS International Certification Services, Inc. as Regulatory Services Manager. He coordinates all CE Marking business in North America. Concerning medical devices, he manages the North American Operations for quality system registrations of medical device companies under ISO 9001:2000, ISO 13485:1996 and 2003, Medical Device Directive 93/42/EEC, and the Canadian Medical Device Conformity Assessment System. He is responsible for liaising with the SGS United Kingdom, Ltd office for CE Mark, the SGS Canada ICS office for CMDCAS, and for the overall delivery of services in compliance with SGS ICS Quality Policy.

Mr. Amundson has spent 19 years working in various positions within SGS and has been a Lead Assessor registered with RAB, an ASQC CQA, and is currently a member of TC 210, AAMI, and MEDEC.

CAPA: Studies in Litigation

Patrick J. Reda
Litigation Associate
Kenneth B. Moll and Associates

Details coming soon...

Managing Field Corrective Actions (Corrections and Removals)

Larry Pilot
Partner
McKenna, Long and Aldridge LLP

Details coming soon...

Design Controls: Management's Tool for Commercial Success

Bob Dicheck
Vice President
World Wide Quality and Regulatory Affairs Inverness Medical Innovations / Unipath

This presentation will address the practical application of design controls to rapidly drive R&D projects through commercialisation and the product life cycle.

It will cover the transition from a bureaucratic environment to an innovative approach for robust design and development where the regulatory mandated design controls help reinforce the business direction and outcome.

You will hear how FDA investigators’ recommendations helped senior management better define organizational roles, responsibilities, authorities, and accountabilities by utilizing design controls as a business strategy.

The benefits of using internal audits will also be discussed as a learning tool for project teams to understand the key components of good design controls such as planning, technical and managerial reviews, design verification and validation, risk assessment, and Design History Files.

Incorporating Design Controls Into a Fast and Flexible Development Process

Glenn Gerstenfeld
Director of Quality Assurance/Quality Systems
GMP Companies, Inc.

Jan Wells, PMP
Director of Program Management
GMP Companies, Inc.

This presentation goes beyond the basics of incorporating design controls into your product development process. It covers what you may not know about development, and the secrets to success in implementing a fast and flexible development process in a start-up medical company.

General Principles and Case Studies in Process Validation

Cal Bowman JD RAC AQ, CQM, CQA
Vice President of Compliance and Quality, Dow Pharmaceutical Sciences

• Review of Principles of Process Validation

• Sterilization

• HEPA Air Systems Validation

• Compressed Air
  
• Water Systems
  
• Status of Cleaning Validation

Compliance at a Fraction of the Cost -- Design Verification & Product Safety: Industry Benchmarking Study

Paul Adam, Manager
Product Development Productivity
Medrad, Inc.

Wayne Mackey
Principal
Product Development Consulting, Inc.

• Best practices from six leading medical device companies to reduce design complexity

• Focused on requirements, product safety, verification and organization

• Comparative data to distinguish the best from the rest

• Keys to streamlining verification practices

• Efficient and effective implementation of product safety controls

• Implementation details resulting in compliance at a fraction of the cost

Feature Presentation: The Standardization Crutch

John Glaccum
Ethicon Endo-Surgery

• How processes can be over-pushed as "fill out this standard form"

• How we "blew up" our current "documentation" process and made a "New Product Development" process

• How we incorporated these changes in our organization's processes (Taking a cross-functional team of practitioners, and building it together
  rather than handing them a ready-made process without their input)

The Seven Habits of Highly Effective Risk Management Systems

Kevin M. Quinley
CPCU, ARM AIC, AIM, ARe
Senior Vice President, Risk Services
MEDMARC Insurance Company

• Focus on prevention

• Prudent document retention and communication management

• Quick investigations

• Sees FDA compliance as just the start

• Learning from "closed" claims

• Treats field reports as early weathervanes of approaching storms

• Views risk management as everyone's job

Managing For Quality – A Value Added Activity

John Malloy
President
John Malloy and Associates, Inc.

• Communication between mid and executive management

• CAPA Connector (only section that specifically requires feedback to management)

• What to Keep Your Eyes On

• Conversion of the Compliance Perspective to the Management Perspective

• The Role of the Management Representative

Shedding Light on FDA Expectations for Software Validation Practices

Ronald K. Moy
Associate Director of Quality
Quintiles Consulting

Software is an important and continually growing element in today's products, services and quality systems. This discussion will explore the issues surrounding software validation practices, and shed light on FDA's expectations, and how FDA investigators conduct reviews of software validation activities.