Stephen Cook– VP, Quality as well as Computer Software Assurance– Compliance Group Inc
. Stephen Cook has 20+ years of experience in the area of computer system systems recognition and also is a specialist on FDA’s upcoming support on Computer Software Assurance (CSA).
Sachin Bhandari Chairman, ISPE, Steering Committee Member – GAMP India CoP. Experienced expert in Pharmaceutical and also health care conformity domain name with vast experience in GXP, 21 CFR component 11, GAMP 5 and also various other conformity needs as well as adherence.
Harsha Chulki: Head of Global IT Quality, Compliance & CSV – ICU Medical Inc.-Harsha is accountable for guaranteeing premium quality as well as certified remedies are established as well as released by ICU Medical’s Global IT company. A principal in the change of managed systems.
In this webinar listen to straight from the “FDA/industry CSA Team participant”, including sector professionals, that will certainly carry out a panel conversation, regarding the upcoming draft Computer Software Assurance (CSA) draft advice from FDA’s CDRH department. The assistance covers the concepts of risk-based CSA, offer FDA’s point of view, as well as share countless real-life success tales as well as their resulting worth.
ISPE GAMP ® worldwide management highly sustains this danger- as well as quality-based strategy to the guarantee of electronic systems and also thinks that existing ISPE GAMP ® advice is currently totally straightened as well as regular with such a method, consisting of brand-new support coming this year from the CDRH.
Regarding the Panel
Khaled Moussally– EVP, Clients & Regulatory Relationships– Compliance Group Inc.- Khaled Moussally has 25+ years of experience in the Life Sciences market and also is a well-respected as well as widely known idea leader on Quality & Compliance. Khaled is a vital participant of the FDA Case for Quality/ “FDA CSV Industry Team”, an adding writer to the upcoming FDA advice on Computer Software Assurance (CSA) and also an adding ISPE GAMP participant to the Appendix of the Good Documentation Guidance on Data Integrity.