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Strict change-control systems are essential to protect customers from failed drug or biologic products, which makes good business sense for manufacturers. Failures have caused "real tragedies" in the past, Barbara Immel, president of Immel Resources and editor of the Immel Report, said in a recent FDAnews audioconference. Read More
FDA inspectors are likely to focus more on drug and device company complaint-handling efforts in 2007 because they are tied so closely to patient safety, Sparta Systems VP of Marketing and Product Development Steve Cagle recently told PIR.
The SEC has notified Inspire Pharmaceuticals that its staff will recommend bringing civil action against the company and two executives for alleged violations of securities law.
The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at a recent industry conference.
The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at a recent industry conference.
A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer told D&DL (see related story).
Devicemakers can help ensure smoother FDA inspections of their facilities by improving their communication with inspectors and making sure their regulatory affairs personnel fully understand the quality system regulation (QSR), experts say.
Regulations aimed at protecting IT operations and edata aren't going away and companies should evolve their compliance environments into cost-effective, sustainable programs, according to experts speaking at a Sept. 13 webinar, "The Evolution of Controls for Compliance -- The Next Phase: Controls Automation & Monitoring."
Achieving a "paperless" lab takes enormous work, including substantial procedural and possibly organizational changes, but the effort can pay off in a year and provide benefits far beyond 21 CFR Part 11 compliance, experts told PIR last week.