Best practices and strategic approach for evaluating computer systems
Food manufacturers are required to “prominently’ display clear label information
Latest trends in human error issues in the industry
Waive the requirement for “informed consent” in specific cases
Learn how to prepare the necessary documents and register your product with the Chinese regulatory authorities
When a sterility test failure occurs
Understand the basics of SPC, as well as the effect of variation on quality and the difference
Understand the nature, severity, or frequency of suspected problems reported in adverse
Electronic Records & Electronic Signatures
The use of social media is ripe for regulatory blunders if your not paying attention.
Complexity of providing safe food and examine the factors that impact on microbiological food safety
Protects your firm from more severe action by the FDA
A program that will be compliant to the FDA requirements
Detection an out-of-specification result to informal and formal laboratory and batch investigations
General public assumes manufactured pharmaceutical products are safe
Computer system validation can be applied to mobile applications
Premarket Approvals Premarket approval (PMA) are required by The Food and Drug
Failure to provide the correct information creates costly delays
The limitations of how potability is currently defined and examine options for mitigating
What happens when your product is detained?
Device makers face a market upheaval in the EU. A new set of rules
CAPA is arguably the most important process in a quality management system
What are the key elements of a PMS system?
Identify New Product transfer process
Current trends in cybersecurity threats to medical devices
Global agencies expectations of analytical equipment qualification along with the development
Quality Control Laboratory plays an important part role
A failure to do things correctly will create a "bad actor" image
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system.
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.