|This course will meet your requirement for annual GMP training|
? EMA has Brexited to Amsterdam;
? PIC/s is pushing ahead with their workplans
? Why has FDA pre-empted ICH yet again, with a draft guidance on Continuous Manufacturing (what will be ICH Q13?)
? ICH Q12 is well along the road, Q13 and 14 are coming along
? Under Annex 21, the concept of “importer of medicinal products” is likely to change, as physical and financial flows will have to match. WHAT does this mean?
q What’s hot: inspectional findings
q What’s hot: CAR T cells, HCT/Ps and FDAs inspectional report 2014 – 2018
q ATMP GMPs (brief)
q PIC/s Guidance on Classification of Inspectional Deficiencies
An audit roadmap
q FDAs Guidance on Recalls
q Annex 21: Guidance for Importers
q Draft revision of Annex 1 on Sterile Products – current status
q Data Integrity, OOS, Unusual results – where do we stand?
q ICH Q12 – Lifecycle Management of Processes
q ICH Q13 – Continuous Manufacturing of DS and DP
along with FDA’s Guidance: Quality Considerations for Continuous Manufacturing
q ICH Q14 – Analytical Procedure Development (with USP <1220> AP Lifecycle
q Serialization where are we
q Annex 1 (brief) and 2 status
Objective: Provide a rapid update of GMP related regulations, their ongoing development and interpretation. This interactive workshop will allow participants to gain a new perspective on old topics and figure out what the inspector is focusing on and where the next surprise might be.
Benefits Participants will come away with a list of sources for GMP updates and a rapid overview of the changes that have been recently implemented and those under consideration / comment.
Content: The course will address all of the checkboxes above and more and will pull together the threads to allow you to understand where to focus limited resources for maximum return on investment
|23-09-2019 kl.:09.00 til kl.:16.00|
Symbion, Fruebjergvej 3, 2100 København Ø
Der vil være morgenmad fra kl. 8.30
|Max antal deltagere: 70, der er 55 pladser tilbage|