FOUR WAYS A CONSULTANT CAN HELP PREPARE FOR AN FDA INSPECTION
- Conduct a mock audit or gap assessment to understand where the organization needs to focus improvement. Routine Mock FDA Audits can help your organization prepare for an official audit by outlining audit observations, especially repeat observations, including unmet regulatory requirements; products that do not meet safety or performance criteria; inaccurate documentation; and/or personnel responsible for maintaining regulatory factors within the organization. A gap analysis reviews internal processes and compares them to active standards, good practices, laws, regulations, etc. to ensure they are compliant. Gap analyses can be performed on an entire organization, standard operating procedures, manufacturing practices, and more. The first step is to report what is compliant and then to identify what’s missing, or the “gaps”, from the desired standard.
- Provide cGMP training to better understand the requirements of the FDA. Whether you are a senior manager or a line inspector, every professional in the life science industry benefits from detailed GxP training. A solid FDA, GCP, and GMP program ensures quality, safety, and compliance. Compliance Insight develops impactful, on-site educational programs that provide product developers and manufacturers with the tools they need to make quality conscience and compliant decisions. We provide GCP, GMP and GSP training that helps institute the type of approaches that encourage consistency and drive corporate and product success.
- Join at the time of inspection as an advisor to the company to fully understand the inspector’s findings and provide immediate remediation suggestions. Compliance Insight, Inc. consultants provide an average of 20 years’ experience to our clients. This experience includes direct work experience with the FDA and /or industry to provide the highest quality inspection and remediation results.
- Review policies and procedures followed during the pandemic to protect product quality. The Coronavirus Aid, Relief, and Economic Security (CARES) Act was instated to provide emergency assistance and health care response for individuals, families, and businesses. In relation to the pharmaceutical and medical device industries, it provides mitigation for medical device and drug shortages, facilitates the Biomedical Advanced Research and Development Authority (BARDA) collaboration with the private sector on pandemic-related products, and provides funding to the Public Health and Social Services Emergency Fund and BARDA. It also allows for FDA issuance of emergency use authorizations (EUAs), for which Compliance Insight, Inc. consultants can offer guidance.
Our services include, but are not limited to:
- PAI Preparation/Mock Audits
- Laboratory Audits
- Due Diligence
- Contract Manufacturer/Vendor Audits
- GXP Gap Analysis Audits
- Part 11 Compliance Audits
- Clinical Trial Investigator Site Audits
- Contract Research Organization Audits
- IRB Audits
- Clinical Site Audits
- CRO Audits