Adam Fleming

Did you know that your use of the social media in certain ways can be violative of the sweeping and highly generalized definition that the FDA has of labeling? This definition is so broad in its reach...

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and...

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the...

Buying or selling a business is not the same as doing the same with consumer items. It requires a lot of thought and insight, and having to answer many questions about the business. The impact the...

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared...

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is "Supervising a...

SharePoint is now almost the accepted and standard mode for organizations to share relevant information and files with other people, both in the company and outside. The main benefits of SharePoint...

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, "Complaint Handling" on February 6. Peggy J. Berry...

Isn’t supplier management all about managing your suppliers? Well, at first glance, it appears as simple as that. In fact, it is the easiest way to understand the term. Yes, from a semantic and...

For anyone that wants to know the mystery behind leadership skills, the answer is simple: there isn’t any. Surprised? Well, let me qualify my description if I’ve confused you: there are ways by which...

As healthcare and higher education institutions face nearly unprecedented turnover and reduced employee engagement, organizations are forced to look at ways to change the situation. Cross training is...

We have heard about the very high standards being set by the airline industry around the world, especially so in advanced economies such as the US. Much of this is owed to the efforts and purpose of...