Implementation of the Lifecycle Approach to Process Validation Statistics
Maneesha Altekar, PhD
The ISPE 2016 Process Validation Statistics Conference is in its 3rd year, continuing with its successful tradition of bringing together pharmaceutical leaders within the industry and regulatory authorities to share their thoughts in the implementation of the lifecycle approach to process validation. The keynote talks are always inspiring – and this year is no exception:
The ISPE 2016 Process Validation Statistics Conference will feature:
Advances in statistical applications to process validation Stages 1-3 along with applications and case studies
Introducing attendees to newer concepts in process validation such as applications to Packaging and Continuous Manufacturing
Panel discussions at each session, which will allow for a more interactive opportunity for you to engage with the speakers and each other
Polling throughout the meeting that will provide invaluable benchmarking information for you and your organization
Networking breaks allowing for an opportunity to catch up with old colleagues and make new contacts
As always, there will be a mixed group of statisticians and process validation practitioners, representing every category of pharmaceutical manufacturing (small molecule, large molecule, devices, and more). For those of you who are not statisticians but want to know more about the statistics used in process validation and be better prepared for the conference sessions? There will be two 90-minute session on the first day of the conference to make you become better acquainted with some of the key topics that will be discussed during the sessions:
By the ISPE Regulatory Team
ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and...
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium was titled “Thriving at 50 and Striving Forward” and was aimed at promoting and...