Newsletter - July 28, 2016
FDA Approval Rate Shows Indian GMP Sites Are in Good Compliance
Negative audit findings make headlines every time a site in India is found to be in violation of GMP requirements by US FDA. For the last few years, negative news about drug manufacturing facilities in India dominated public discourse so much that it has become a cliché to use findings at sites in India for training in what not to do when it comes to GMP compliance. We wondered several times last year if Indian GMP sites were indeed that bad. Read More..
Email Leaks, Politics and FDA-Regulated Industry
An email leak from a Democratic National Committee (DNC) led to the Chair of the DNC losing her job and the leader of the party barely surviving a major crisis on the eve of the convention. This followed concerns of security of personal and official emails. This episode highlights once again the high-risk of electronic communications for all organizations. Emails are not private and we are accountable for everything we write. Read More..
FDA Approval Rate Shows Indian GMP Sites Are in Good Compliance
Negative audit findings make headlines every time a site in India is found to be in violation of GMP requirements by US FDA. For the last few years, negative news about drug manufacturing facilities in India dominated public discourse so much that it has become a cliché to use findings at sites in India for training in what not to do when it comes to GMP compliance. We wondered several times last year if Indian GMP sites were indeed that bad. Read More..
Email Leaks, Politics and FDA-Regulated Industry
An email leak from a Democratic National Committee (DNC) led to the Chair of the DNC losing her job and the leader of the party barely surviving a major crisis on the eve of the convention. This followed concerns of security of personal and official emails. This episode highlights once again the high-risk of electronic communications for all organizations. Emails are not private and we are accountable for everything we write. Read More..
