Posted on 27. Nov, 2013 by Karl Kapp.
Recently, the FDA issued a guidance update to industry and stakeholders such as consumer interest groups, academia, and other regulatory groups concerning its current thinking related to Good Manufacturing Practices (GMPs) for cosmetics. Check out the entire document at Guidance for Industry: Cosmetic Good Manufacturing Practices. If you work within the cosmetics industry, the document [...]
The time has come to purchase a new Learning Management System (LMS), which is a big investment. However, implementing the right LMS can have a positive financial impact on the organization so you want to make the right decision. When choosing an LMS, there are a number of factors to consider that impact the overall [...]
Posted on 15. Nov, 2013 by Karl Kapp.
When a company uses Third Party Sales and Marketing Intermediaries to assist in the marketing, sale or distribution of its products to end users it faces particular compliance risks. These risks can have serious implications on the organization and need to be properly managed. AdvaMed (Advanced Medical Technology Association) and Eucomed have responded to these [...]
The Health Insurance Marketplace is a government program which is part of President Barack Obama’s Patient Protection and Affordable Care Act (PPACA). The Health Insurance Marketplace is designed to provide families and small businesses that don’t currently have insurance, or are looking for a better deal, a way to find health coverage that fits their [...]
Posted on 31. Oct, 2013 by Karl Kapp.
Acknowledging the complexity and size of the global drug industry and its own inspection limitations, the FDA continually emphasizes the accountability of the industry for ensuring Good Manufacturing Practices (GMPs) compliance and product safety. This is important because more than 40% of the finished drugs sold in the US are made overseas; more than 80% [...]
The decision to purchase, build or even re-evaluate your existing Learning Management System (LMS) can be daunting. You want to ensure you purchase or maintain the right system, because when poor decisions are made or an outdated system is used, the Learning Management System can actually become a deterrent to good training and hinder an [...]
Posted on 10. Oct, 2013 by Rob Sims.
Managing third party and global distributors remains the top challenge for medical device compliance teams, as noted during a panel session at AdvaMed’s annual MedTech conference on Monday, September 23rd in Washington, DC. The panel featured Daniel Garen, SVP & Chief Compliance Officer at Wright Medical Technology, Inc., Tom Schumacher, Vice President, Chief Ethics & [...]
Not all regulatory agencies look for the same issues and not every inspector from every agency looks for the same issues either. However, the European Medicines Agency (EMA) has clarified what its inspectors expect in the audit reports from Active Pharmaceutical Ingredients (API) manufacturers and suppliers in the EU. Here is what EMA has indicated [...]
Posted on 04. Oct, 2013 by Rob Sims.
We know that FDA officials want GMP training to be effective, but how are companies demonstrating this? I caught a strong sense of the FDA’s expectations for training during last year’s FDA Inspections Summit held in Bethesda, MD. An FDA Investigator presented the QSIT inspection process and as she walked through the “product and process [...]