Under cGMP, 'change' means creating a compliance setting that fosters continual improvement. The FDA considers change management, or 'change control,' as critical to compliance, but offers limited guidance on how to perform it effectively.
According to recent research, the global pharmaceutical packaging market is forecasted to reach more than US$80 billion in revenue by 2020. Take a look at this article to see packaging investments, serialization updates, labeling and artwork challenges, and more.
Expert Insight into Top Pharmaceutical Challenges Surrounding Serialization: Aggregation and CMO Integration
Past speakers, Matt Sample and Christopher Howell, spoke with us about the top pharmaceutical challenges surrounding Serialization: Aggregation and CMO Integration. Both speakers shared their unique perspectives on the topic and also expressed what they were most excited to learn about at the upcoming event.
Let's be honest--your ultimate objective is to make your cold chain a world-spanning behemoth with tentacles in all nations. We want to help: to this end, we have complete a multi-part eBook to facilitate your conquest. This eBook includes perspectives from six speakers from top industry companies, focusing on regulations, packaging, logistics, and security in the international cold chain.
Working within the ever-changing cold chain requires extremely detailed planning, extensive preparation, and precise execution. While these techniques vary immensely across the globe, risk management is necessary and standardization is the key goal for everyone. This complimentary whitepaper dives deeper into this idea, with specific focuses on supply chain security, validation & lane qualification, data monitoring in shipping lanes, and stability budgets.
Matt Sample, from AmerisourceBergen describes his experiences using DSCSA Serialization and Pilot Programs inside his organization in regards to traceability.
Ahead of our first ever Pharma Logistics Week, we sat down with four of the industry's leading experts to get their perspective on topics specific to each of their areas of expertise. Receive insight on topics that include roadblocks and supply chain challenges, clinical and commercial operations, validation protocols and many more. Through this EBook, you'll gather the resources necessary to bring your cold chain to the next level.