Compliance Tips

  • FDA Calls for Corporate Commitment and Leadership at PolyCarbon Industries

    Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. The... Read More »

  • Compliance Tips For cGMP Inspections

    Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at your company without any prior notification, it is important that you... Read More »

  • FDA Inspection Wizard – What’s Scary Can Turn Out to Be a Piece of Cake

    Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm... Read More »

  • How to Perform a Mock Audit

    After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for... Read More »

  • What You Need to Know About Vendor Audits

    A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in... Read More »




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