Medical Devices Webinars

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, pos...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

The USDA announced the National Bioengineered Food Disclosure Standard on December 20, 2018. The National Bioengineered Food Disclosure Law, passed by Congress in July of 2016, directed USDA to establish...

By Internal Team

• 60 Mins

Highlights will include an intro to Preventative Controls, leading into minimal recommended preparation steps for handling Prop 65 requirements, what’s needed to incorporate in your food Safety Plan, focu...

By Internal Team

• 60 Mins

Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA'...

By Internal Team