hour(s)
Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
GDocP the mainstay of GMP regulations in a pharmaceutical organization. Appropriate documentation illustrates a detailed picture of all the manufacturing operations done in the past and what is in process and, thus, serves as a basis for planning what has to be done in the future. The quality assurance system of a company regulates the documentation of all processes. It serves as a foundation tool to audit manufacturing and testing operations in a company. Regulatory inspectors rely on company documents and records to conduct inspections of a company’s manufacturing sites.
Therefore, an effective documentation system reflects the competency of the quality assurance system of a company.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Introduction
Glossary
Conclusion
Evaluation
$60.00 / year
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