Compliance in Biotechnology: Practical Guide

By (author): Cristina Messias da Silva

This comprehensive guide on compliance in biotechnology provides an in-depth roadmap for navigating the regulatory, ethical, and operational challenges unique to the biotech industry. Covering essential topics such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and quality management, this guide explores the entire product lifecycle - from research and development to clinical trials, manufacturing, and post-market surveillance. 

Each chapter delves into the impact of emerging technologies like artificial intelligence, blockchain, and big data, and addresses future trends including personalized medicine, environmental sustainability, and global regulatory harmonization. 

With a focus on fostering a culture of compliance, this guide equips biotech professionals with the knowledge and tools necessary to uphold the highest standards of safety, quality, and integrity in an evolving regulatory landscape. Perfect for industry professionals, this handbook is both a reference and a practical resource for achieving compliance excellence in biotechnology.

Book Format: Kindle / Paperback