CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program
By J Rodriguez
4.5/5
()
Currently unavailable
Currently unavailable
About this ebook
CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.
- Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action
- Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail
- Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately
J Rodriguez
Jackelyn Rodriguez has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. Ms Rodriguez is the President of Monarch Quality Systems Solutions, a consulting firm serving in the technical and regulatory compliance capacity for several Pharmaceutical, Biologics and Medical Device manufacturers. Her consulting activities place emphasis on all aspects of regulatory compliance, training, Mock FDA audits/assessments, regulatory affairs and various FDA-related activities. Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry.
Related to CAPA in the Pharmaceutical and Biotech Industries
Related ebooks
Equipment Qualification in the Pharmaceutical Industry Rating: 4 out of 5 stars4/5Medical Device Reporting A Complete Guide - 2019 Edition Rating: 0 out of 5 stars0 ratingsFundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines Rating: 5 out of 5 stars5/5Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Rating: 0 out of 5 stars0 ratingsClinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Rating: 3 out of 5 stars3/5Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS Rating: 0 out of 5 stars0 ratingsPrinciples of Parenteral Solution Validation: A Practical Lifecycle Approach Rating: 5 out of 5 stars5/5How to Integrate Quality by Efficient Design (QbED) in Product Development Rating: 0 out of 5 stars0 ratingsHandbook of Investigation and Effective CAPA Systems Rating: 0 out of 5 stars0 ratingsRisk Management for Medical Device Manufacturers: [MD and IVD] Rating: 0 out of 5 stars0 ratingsPractical Approaches to Method Validation and Essential Instrument Qualification Rating: 0 out of 5 stars0 ratingsMedical Device Reporting A Complete Guide - 2020 Edition Rating: 0 out of 5 stars0 ratingsConcepts of Quality Management in Pharmaceutical Industry Rating: 0 out of 5 stars0 ratingsQuality Assurance and Quality Management in Pharmaceutical Industry Rating: 4 out of 5 stars4/5Introduction to Quality by Design for Pharmaceuticals Rating: 0 out of 5 stars0 ratingsHow to Validate a Pharmaceutical Process Rating: 4 out of 5 stars4/5GMP in Pharmaceutical Industry: Global cGMP & Regulatory Expectations Rating: 5 out of 5 stars5/5Process Validation A Complete Guide - 2020 Edition Rating: 0 out of 5 stars0 ratingsCGMP A Complete Guide - 2021 Edition Rating: 0 out of 5 stars0 ratingsPharmaceutical Quality by Design: A Practical Approach Rating: 0 out of 5 stars0 ratingsMedical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness Rating: 0 out of 5 stars0 ratingsCGMP Starter Guide Rating: 4 out of 5 stars4/5Quality Risk Management in the FDA-Regulated Industry Rating: 0 out of 5 stars0 ratingsGuidebook for Drug Regulatory Submissions Rating: 0 out of 5 stars0 ratingsThe Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology: Points to Consider Rating: 0 out of 5 stars0 ratingsHow to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval Rating: 0 out of 5 stars0 ratingsGood Laboratory Practices and Compliance Monitoring Rating: 0 out of 5 stars0 ratingsPharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems Rating: 5 out of 5 stars5/5Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process Rating: 2 out of 5 stars2/5A History of a cGMP Medical Event Investigation Rating: 0 out of 5 stars0 ratings
Medical For You
The Vagina Bible: The Vulva and the Vagina: Separating the Myth from the Medicine Rating: 5 out of 5 stars5/5The Lost Book of Simple Herbal Remedies: Discover over 100 herbal Medicine for all kinds of Ailment Inspired By Barbara O'Neill Rating: 0 out of 5 stars0 ratingsHolistic Herbal: A Safe and Practical Guide to Making and Using Herbal Remedies Rating: 4 out of 5 stars4/5Mediterranean Diet Meal Prep Cookbook: Easy And Healthy Recipes You Can Meal Prep For The Week Rating: 5 out of 5 stars5/5The Hormone Reset Diet: Heal Your Metabolism to Lose Up to 15 Pounds in 21 Days Rating: 4 out of 5 stars4/5Adult ADHD: How to Succeed as a Hunter in a Farmer's World Rating: 4 out of 5 stars4/5The 40 Day Dopamine Fast Rating: 4 out of 5 stars4/5Mating in Captivity: Unlocking Erotic Intelligence Rating: 4 out of 5 stars4/5David D. Burns’ Feeling Good: The New Mood Therapy | Summary Rating: 4 out of 5 stars4/5The Diabetes Code: Prevent and Reverse Type 2 Diabetes Naturally Rating: 4 out of 5 stars4/5Gut: The Inside Story of Our Body's Most Underrated Organ (Revised Edition) Rating: 4 out of 5 stars4/5Tight Hip Twisted Core: The Key To Unresolved Pain Rating: 4 out of 5 stars4/5What Happened to You?: Conversations on Trauma, Resilience, and Healing Rating: 4 out of 5 stars4/5Peptide Protocols: Volume One Rating: 4 out of 5 stars4/5Women With Attention Deficit Disorder: Embrace Your Differences and Transform Your Life Rating: 5 out of 5 stars5/5Lifting the Fog: A specific guide to inattentive ADHD in adults Rating: 4 out of 5 stars4/5Living Daily With Adult ADD or ADHD: 365 Tips o the Day Rating: 5 out of 5 stars5/5The Song of the Cell: An Exploration of Medicine and the New Human Rating: 4 out of 5 stars4/5ATOMIC HABITS:: How to Disagree With Your Brain so You Can Break Bad Habits and End Negative Thinking Rating: 5 out of 5 stars5/5Woman: An Intimate Geography Rating: 4 out of 5 stars4/5The White Coat Investor: A Doctor's Guide to Personal Finance and Investing Rating: 4 out of 5 stars4/5The Amazing Liver and Gallbladder Flush Rating: 5 out of 5 stars5/5Herbal Healing for Women Rating: 4 out of 5 stars4/5The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet Rating: 4 out of 5 stars4/5
Reviews for CAPA in the Pharmaceutical and Biotech Industries
6 ratings0 reviews