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60 Mins
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the pro...
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maint...
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are als...
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will b...
This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in...
Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risk...
This session explores the elements required for a successful technology transfer between various sites. It is intended for anyone who may be involved in the transfer of information between groups or sites...
Technical Writing is required by everyone at some point in their careers. All of us must document something that we have written or defended any work that we have performed. Often this documentation takes...
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration...