Combination Products: Implementation of cGMP Requirements (single user digital version)

Jul 2013
PDA Item Number
PDF Single user
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The goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP in a combination product environment and also includes information from leaders in the industry regarding the unique requirements for several common combination products situations. PDA hopes that this book can answer many of the reader's questions on the evolving world of combination products.

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Format: PDF (1 file 4.76 MB)

Hard cover book is not available.

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

Foreword by Rich Levy

    1. Introduction by Lisa A. Hornback
    2. Quality System Development to meet Combination Product Requirements by Lisa A. Hornback
    3. Risk Management for Combination Products by Edwin Bills
    4. Design Inputs and Associated Design Verification and Validation — A Primer on Applying Human Factors Engineering by Edwin W. Israelski
    5. Purchasing Controls and Supplier Relationships by Lisa A. Hornback
    6. Cross Labeled Combination Products by Suzanne O'Shea
    7. Regulatory Strategies for Combination Products by William D'Agostino
    8. Development of a Drug/Autoinjector Combination Product: A Case Study by Mark A. Chipperfield, Ruby Gulati and Jennifer Mercer
Federal Register: Combination
Product Final Rule (With Preamble)

About the Authors

Lisa A. Hornback, Principal Consultant of Hornback Consulting, LLC, has over 15 years experience regarding interpretation and implementation of FDA regulatory requirements for pharma, devices, and biologics. Ms. Hornback is currently a Compliance Consultant, where she provides expertise and assistance to FDA regulated industry in the US and overseas in resolving FDA compliance issues and developing compliant and effective quality systems. Previously, Ms. Hornback was an FDA Field Investigator and the FDA's Midwest Regional Medical Device Expert. Ms. Hornback holds a Bachelor of Science in Medical Technology and has worked extensively in the hospital setting.