Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device IndustriesThis book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries. |
From inside the book
Results 1-5 of 52
Page v
... QUALITY BY DESIGN vii 11 25 33 CHAPTER 5 OUTSOURCING 115 45 APPENDIX TO CHAPTER 5 51 CHAPTER 6 ELECTRONIC SUBMISSIONS 57 APPENDIX TO CHAPTER 6 63 CHAPTER 7 EMEA / FDA COORDINATION 81 APPENDIX TO CHAPTER 7 89 CHAPTER 8 MANAGING FDA ...
... QUALITY BY DESIGN vii 11 25 33 CHAPTER 5 OUTSOURCING 115 45 APPENDIX TO CHAPTER 5 51 CHAPTER 6 ELECTRONIC SUBMISSIONS 57 APPENDIX TO CHAPTER 6 63 CHAPTER 7 EMEA / FDA COORDINATION 81 APPENDIX TO CHAPTER 7 89 CHAPTER 8 MANAGING FDA ...
Page viii
... Quality by Design ( QbD ) is an evolving FDA initiative for automating signifi- cant portions of the quality control process . Chapter 4 provides an explanation , and it discusses the ways in which an investment in a QbD system can ...
... Quality by Design ( QbD ) is an evolving FDA initiative for automating signifi- cant portions of the quality control process . Chapter 4 provides an explanation , and it discusses the ways in which an investment in a QbD system can ...
Page 2
... Quality by Design ( QbD ) initiative , which can reduce regulatory review times and expenses by building in and documenting quality controls and assurance , rather than restructuring or retesting while a product sits in quarantine ...
... Quality by Design ( QbD ) initiative , which can reduce regulatory review times and expenses by building in and documenting quality controls and assurance , rather than restructuring or retesting while a product sits in quarantine ...
Page 5
... quality in ” program is designed, replacing expensive emergency responses with cost - controlled quality planning. Once the plan is completed and all significant problems are remediated, a final audit report is ... QUALITY BY DESIGN 5.
... quality in ” program is designed, replacing expensive emergency responses with cost - controlled quality planning. Once the plan is completed and all significant problems are remediated, a final audit report is ... QUALITY BY DESIGN 5.
Page 6
... design space analysis results in the determination of the appropriate tolerance levels of quality controls and system performance . The monitoring of those controls and elements is defined as process analytical technology ( PAT ) . PAT ...
... design space analysis results in the determination of the appropriate tolerance levels of quality controls and system performance . The monitoring of those controls and elements is defined as process analytical technology ( PAT ) . PAT ...
Other editions - View all
Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and ... Sandy Weinberg No preview available - 2011 |
Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and ... Sandy Weinberg No preview available - 2011 |
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acceptable analysis application approach appropriate approval audit auditor automated biologics cGMPs clinical Common Technical Document condoms consultant control articles cost containment Cost-Contained Regulatory Compliance CP-Bio credible defined design space documents Drug Administration drug discovery eCTD backbone files effective electronic submissions employees European Medicines Agency Evaluation expense experience expertise facility FDA and EMEA FDA investigators FDA visit FDA's folder Food and Drug guidance guidelines identified implementation inspection issues laboratory manufacturing Manufacturing Practices Medical Device Industries ment module monitoring operational definition organization outsourcing pharmaceutical potential problems Process Analytical Technology protocol QA/QC quality assurance Quality by Design quality control regulation regulatory agencies regulatory costs requirements responsibility result risk assessment safety sample Sandy Weinberg significant SOPs specific Standard Operating Procedures strategy testing tion Trace Matrix utilized validation Wiley & Sons Yes No N/A