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eBook Library
- eBook
21 CFR 117
21 CFR 117 – CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
- eBook
21 CFR Part 820
Quality System Regulation Title 21 – Food and Drugs, Volume 8 Chapter I – Food and Drugs Administration Department of
- eBook
21 CFR Part 806
Medical Devices; Reports of Corrections and Removals Title 21 – Food and Drugs, Volume 8 Chapter I – Food and
- eBook
21 CFR Part 610
General Biological Products Standards Title 21 – Food and Drugs, Volume 7 Chapter I – Food and Drugs Administration Department
White Paper
Navigate FDA Warning Letters: 4 Main Causes from John Daley
This White Paper provides an in-depth review of contemporary capabilities and solutions for effectively integrating third-party CMOs and other suppliers with GMP manufacturing quality systems and operations. It explores problems with quality oversight in the third party supply chain; how to think differently about managing the third-party supply chain; considering a technology framework to support improved third-party supply chain effectiveness; and how to "make it happen" for your company. This White Paper will stimulate your thinking and engage readers with questions about changing the game with people-process-technology third party supply chain approaches.
One Pager
6 Reasons to Work with Interim Expert Placement Firms
The need to constantly swap internal resources to keep projects on-track can severely limit FDA-regulated companies from maintaining quality and staying in compliance. Instead of improving operations, preparing for upcoming inspections, optimizing your QMS, keeping that application filing on schedule, or otherwise performing at your peak, you’re wasting time looking for people to keep the company moving forward.
eBook
21 CFR 117
21 CFR 117 – CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Case Study
Managed Service Solution for Pharmaceutical Annual Product Review (APR)
Transition to a Managed Service for the APR process for this leading OTC healthcare company was a significant deviation from normal company practices, but also, a significant success! Trust in our firm as a preferred service provider played a large role in their willingness to adopt this service model. The Client has realized significant benefits in improved consistency of documents; improved process definition and governance; and overall, a significantly improved compliance profile. On-time completion of APR reports improved steadily as process improvements were introduced, and has been consistently at 100% since the deployment of the full solution. Collaboration between the Compliance Architects® writers and Client staff has grown stronger over time, yielding additional benefits in terms of lower rework and higher levels of report quality.
White Paper
Managing the New Approach: Quality System Documentation
Today, FDA Investigators don't just pore over your documents, they access your computer-based systems to obtain your information directly! The old way of managing FDA Inspections, while still valid, needs to be updated. This White Paper looks at traditional FDA Inspection approaches, the new "live review" approach, impacts from the "live review" approach, and how to best adapt to the "live review" approach.
White Paper
Quality Management in the Third-Party Supply Chain
This White Paper provides an in-depth review of contemporary capabilities and solutions for effectively integrating third-party CMOs and other suppliers with GMP manufacturing quality systems and operations. It explores problems with quality oversight in the third party supply chain; how to think differently about managing the third-party supply chain; considering a technology framework to support improved third-party supply chain effectiveness; and how to "make it happen" for your company. This White Paper will stimulate your thinking and engage readers with questions about changing the game with people-process-technology third party supply chain approaches.
