Biotechnology Webinars

• 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

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...

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

This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. Th...

By Internal Team

• 60 Mins

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risk...

By Internal Team

• 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

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best positio...

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

The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and re...

By Internal Team