Browsing Category Compliance Tips

Latest Trends in cGMP Compliance

Latest FDA and cGMP Compliance News Here are some current cGMP compliance trends we are hearing from some of our industry contacts. We are seeing in the last year or two an emboldened FDA, which is trying to measure up under a Congress more interested in food and drug safety. For example, we have seen [...]

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Category : Compliance Tips

6 Tips to Avoid 510(k) Submission Delays

We often get questions about how medical device companies can minimize delays with FDA in having their device cleared.  Note that some delays are not in the hands of the submitter, but there are surely some easy steps that you can take that will streamline the 510(k) submission process. Here are some easy tips to [...]

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Category : Compliance Tips

Tips and Thoughts on Critical Process Cleaning Procedures

Latest FDA and cGMP Compliance News How hard can cleaning be? That is something that people who are not involved in the production of pharmaceutical products may ask, but not people in the industry. The general thought process in the industry is that cleaning and cleaning validation is a practice that is necessary and unpleasant [...]

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Category : Compliance Tips

No Device Complaints – No Problems? Think Again

Latest FDA and cGMP Compliance News FDA states that a complaint is any written, oral or electronic communication that is alleging there are deficiencies in a product related to the quality, durability, identity, safety, reliability, performance or effectiveness of a medical device after it is released to the market. Note that the ISO 13485 definition [...]

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Category : Compliance Tips

Tips to Qualify Your Pharmaceutical Ingredient Suppliers

  Latest FDA and cGMP Compliance News As most of us know, the globalization of drug manufacturing and the move to the use of many overseas suppliers has greatly increased the complexity and vulnerability of the drug supply chain. That is why supplier and vendor cGMP compliance at all stages – purchasing, manufacturing and distribution [...]

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Category : Compliance Tips &News

Don’t Fight the FDA Auditor! FDA Issues Guidance on How to Avoid Inspection Problems

Latest FDA and cGMP Compliance News FDA has been ramping up its efforts to inspect drug facilities in the last three years or so. Some of the largest pharmaceutical companies have had cGMP inspectors at many of their sites. Drug compounding pharmacies are getting more scrutiny due to a very serious fungal meningitis scandal. FDA [...]

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Category : Compliance Tips

5 Ways to Avoid cGMP Problems With FDA

Latest FDA and cGMP Compliance News Everyone fears getting a 483 or warning letter. These sanctions can lead to serious problems for pharmaceutical companies. cGMP violations are very costly in terms of public image and repairing the damage. We find that most problems can be avoided by following these steps: Ensure full compliance with cGMP [...]

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Category : Compliance Tips

Writing Effective SOPs for Pharma

This is Part II of our article on ensuring effective SOPs in the pharmaceutical industry. A strong SOP program has a solid technology platform that works well with current technologies and can handle the following functions: SOP distribution Validation Testing Recording keeping in formats ready for audit SOPs have to be revised when there is [...]

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Category : Compliance Tips

Ensuring Effective SOPs in the Pharmaceutical Industry

Latest FDA and cGMP Compliance News Every year, FDA hands out plenty of 483s and warning letters, and many of them center on the failure to have or to properly utilize their SOPs, which is really the most fundamental aspect of cGMP rules. The purpose of SOPs in the pharmaceutical industry is clear – to [...]

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Category : Compliance Tips

How Well Do Drugmakers Understand Informed Consent?

Latest FDA and cGMP Compliance News Mark Hochhauser, who is a community member on the North Memorial Medical Center IRB in Robbinsdale, MN, provides some details about problems that he sees with informed consent forms: #1 Be Sure to Proofread Your Consent Many consent forms come into IRBs that have not been carefully proofread. IRBs [...]

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Category : Compliance Tips

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