Description:-

In this webinar we will be undergoing through a series of highly detailed discussions regarding Contract Manufacturing Organizations (CMO) Quality Agreements, topics such as documentation, change control, lab controls, facilities and equipment, sub-contracting, etc by using the power of online conferences. Participants who attend this seminar will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Why should you attend ?

The FDA and EU always have had as a requirement a Control of Suppliers such as Contract Manufacturing Organizations (CMO), but with the new regulatory documents being released there is a new expectation, in this case a written documentation of this control,which is specific to a particular CMOmust be presented as a proof in the form of a Quality Agreement to the FDA / EU inspectors.The exhibitors of this webinar will use their resources such as audio conferences to deeply explain what is expected in the new Quality Agreements from the regulators perspective. In the webinar each section of the Quality Agreements that is proposed gets fully analyzed and if people want to suggest content, it will be written taken in considerations the new guidelines.There will be also be a section on where the two regulatory documents get compared and a discussion of the highlighted differences will be made. For the sake of getting the attendees full understanding of what the expectations are, the latest status of the FDA draft guidance along with some comment from the industry will be discussed.

Areas covered in the session :

• Good Quality Agreement what is it.
• Everything that the Quality Agreement covers
• Responsibilities of the owner vs. contract facility
• GMP Responsibilities
• The new FDA and EU guidelines will be compared