| Would your pharmaceutical company know what to | | | | quality systems gap assessment. These tests are |
| do if the FDA suddenly showed up at your door? | | | | vital for any inspection training that your company is |
| Would your senior management be ready, would | | | | looking for to prepare for your FDA audit. They will |
| your staging room be ready? Would your receptionist | | | | test all procedures and analytical methods to see that |
| be ready to handle the protocol that takes place | | | | they are up to par and can be validated. This includes |
| during an FDA audit? Does your pharmaceutical | | | | methods for testing, sampling, and data evaluation. |
| company have the correct documents in place | | | | They will make sure that all your equipment used for |
| needed for an FDA audit? An FDA citation can set | | | | testing and sampling is properly calibrated, and well |
| your company back months, even years, not to | | | | maintained. Environmental conditions such as humidity, |
| mention the thousands of dollars in fines your | | | | oxygen, temperature, even electromagnetic |
| company is likely to face. If you're not sure that your | | | | interference will all be monitored and controlled. They |
| company is FDA compliant, it would be an excellent | | | | will also work to make sure you have the specific |
| idea to hire an outside pharmaceutical consulting firm | | | | documents in place, such as policies and a specific |
| that specializes in mock FDA audits and regulatory | | | | quality plan. |
| inspection readiness. | | | | A pharmaceutical consultancy firm will help provide |
| This outside pharmaceutical consulting firm will help | | | | your company with the tools and expertise needed |
| you understand why you might be getting audited, | | | | to prepare your organization for any regulatory |
| and prepare your company to pass any surprise or | | | | inspection, surprise or mandated. They will utilize the |
| scheduled regulatory inspections, that might be in | | | | inspection results to give your company a |
| your company's near future. They will help you | | | | competitive advantage, while teaching your company |
| understand the purpose for the inspection, and help | | | | how to stay ready long after the initial mock testing |
| you make ready all the necessary regulatory filing | | | | is completed. Creating an accurate and thorough |
| that may be involved. They will inspect all the logistics | | | | system is key to develop an effective regulatory |
| in and around your company and will work to prepare | | | | training system, which will help your pharmaceutical |
| your site according to FDA standards. They will help | | | | company to pass any FDA inspection every time. |
| to prepare your computer and automated systems | | | | If you liked this article, tell all your friends about it. |
| so that they will be compliant for any regulatory | | | | They'll thank you for it. If you have a blog or |
| review. | | | | website, you can link to it or even post it to your |
| Another important pre-testing measure that an | | | | own site (don't forget to mention as the original |
| outside pharmaceutical consulting firm can offer is a | | | | source. |