Compliance Training on 21 CFR Part 11
At CRQA, we not only provide the highest quality compliance services, but we can also train your teams to proactively deal with compliance issues. Training can be conducted on-site, through WEBEx or at designated training centers. Participants will receive a Certificate of Training in 21 CFR Part 11, good for satisfying GxP training requirements.
CRQA has conducted training sessions on several topics, including preparing for USFDA CSV Inspections, Automating CSV Processes, and 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets. CRQA can create or customize any training program to meet your needs. CRQA can provide any level of service, from teaching a single course to creating and managing your training department.
Part 11 Assessments and Compliance Assessments
Part 11 Assessment are the first steps to controlling your systems. As the USFDA increases regulatory enforcement of 21 CFR 11, one of the most challenging issue for many companies is to know what technological and procedural controls their computer systems require in order to be in compliance. CRQA can assess all of your software, databases, and computer systems and identify what issues need to be addressed for compliance. Good control over your systems would allow you to expand your markets in the pharma industry.
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