compliance

Compliance is Key

Industry experts offered their insights on compliance issues, ranging from GMPs to risk management, at SupplySide West 2014 in Las Vegas. Their tips can help companies navigate supplier qualifications, pass FDA inspections, run effective research studies and avoid serious legal issues that may result from ignorance or misperceptions of regulations.

From a product’s manufacturing stage to its surrounding marketing strategy, compliance is key to success in the market. However, the effort and investment required to maintain quality products, meet with legal counsel for advice and adhere to FDA requirements, all while staying competitive in the market, can seem overwhelming—or even unrealistic.

At SupplySide West 2014 in Las Vegas, industry experts gave 10-minute talks on a wide range of compliance issues to help sort out confusion and alleviate stress surrounding GMPs (good manufacturing practices), clinical trials and risk management. The presentations were given on the SupplySide Central stage, which was sponsored by KGK Synergize and Venable LLP. Their tips can help companies keep up with current compliance issues, many of which have changed tremendously over the years.

For example, when a company receives an FDA warning letter, the consequences today are much different than they have been in the past. Companies must consider the effects of an “Internet age" when weighing legal risks and, as discussed by Angel Garganta, partner at Venable LLC, this makes transparency much more important.

“Before the Internet, warning letters would go from some FDA regional office to whoever, and nobody other than the recipient would know the letter is out there," he explained. “Now, everything is published on the FDA website simultaneously with its issue, and the entire class-action plaintiffs’ bar is constantly looking at that."

Along with transparency, organized documentation, careful quality control (QC) practices and thorough clinical trials can all help companies maintain compliance in today’s industry.

To find out more on compliance issues and what the experts advise, download the Compliance Briefings Report on INSIDER.

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