This workshop will be focused on addressing challenges faced by global, corporate & site professionals before and during a regulatory audit. The individuals will be exposed to the regulatory expectations & best practices for training, preparing, responding during hosting an Unannounced & announced audit?
The workshop modules would be encompassing the global regulatory expectations such as USFDA, EU, PIC/s, HC, Singapore HPA, PMDA Japan, ANVISA, GCC, MCC South Africa, WHO, TGA not limited to mentioned agencies.
Modules would be structured around the regulatory expectations & focused around USFDA & EU type of inspections, compliance Focus, Regulatory Inspection Management and Consequences of Non Compliance.
A key aspect of this recommendation is the mandatory requirement of unannounced audits for all manufacturers certified under one of the European medical device directives (AIMDD, MDD, IVDD) at least once in every third year.
The key discussion point would be as which audit can be performed Unannounced? The goal of the unannounced audits is to assure day-to-day compliance of the manufacturer’s product and quality management systems.