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Combination Products: Implementation of cGMP Requirements
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PDA/DHI Publications

Combination Products
€ 181.00
€ 193.67
  7% VAT included
Implementation of cGMP Requirements
Edition: July 2013
200 Pages
ISBN: 193372272X
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.

Table of Contents:

1. Introduction
2. Quality System Development to meet Combination Product Requirements
3. Risk Management for Combination Products
4. Design Inputs and Associated Design Verification and Validation — A Primer on Applying Human Factors Engineering
5. Purchasing Controls and Supplier Relationships
6. Cross Labeled Combination Products
7. Regulatory Strategies for Combination Products
8. Development of a Drug/Autoinjector Combination Product: A Case Study
Federal Register: Combination
Product Final Rule (With Preamble)
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.
PDA/DHI Publication
GMP Audit Checklist (Download)