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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...
The new rule is highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated...
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...
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in...
Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as u...
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...
The STED-File with the special format as technical documentation covers a lot of countries and help to have technical documentation in global acting companies. A STED-File collect all the data’s and can h...
Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strate...
The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the con...