Come along to PharmOut’s Industry Update Dinner and catch up with your peers, hear about current industry news from the FDA and MHRA and insights from a very busy 2017.
Speakers and topics:
How mature are our validation programmes?
It’s been nearly 7 years since the FDA introduced their 3 stage approach to validation, and 2 years since the last update to Annex 15. Ashley has travelled to the US twice this year to find out what mature validation looks like, and will give his thoughts on how far we still have to come in Australia.
Hot tips from MHRA training
Trev will share his hot tips from the recent MHRA Training in the UK. Straight off the plane and direct to you! As we know EU GMPs do eventually become Australian GMPs so its a great heads up opportunity.
What’s hot and what’s not?
Maria will share what’s hot and what’s not from her recent training with the FDA in Washington D.C. From the top FDA compliance trends to Maturity Models and Continuous Improvement, Maria will discuss examples of specific quality systems and what the good, bad and ugly might look like from an investigator’s perspective.
- Industry Update Dinner (MEL-14-12-17)
14 December 2017
6:00 pm - 8:00 pm
Venue: Clarion Hotel - Melbourne
Venue Phone: +61 3 9878 4111
Venue Website: http://www.clariononcanterbury.com.au/Address: