BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T155746Z UID:b544d012-128a-40ba-80c6-b4a4bd38afc1 DTSTART:20210511T133000 DTEND:20210512T133000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nThis webinar will includ e a detailed discussion of Contract Manufacturing Organizations (CMO) Qual ity Agreement topics such as change control\, documentation\, facilities a nd equipment\, lab controls\, sub-contracting\, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacture rs.
\n\n \;
\n\nWhy Should You Attend
\n\nControl of suppliers such as Contract Manufacturing Organiz ations (CMO) has always been a requirement of the FDA and EU. With the iss uance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.
\n\nThis webinar will provide a tho rough understanding of the content that is expected in Quality Agreements from a regulatory perspective. Each proposed section of a Quality Agreemen t is fully analyzed and suggested content is written with the new guidelin es taken into consideration. Comparison of the two regulatory documents wi ll be presented with differences highlighted and discussed. The latest sta tus of the FDA draft guidance will be discussed and a review of comments f rom industry is included.
\n\n \;
\n \;\n\nThe who and what of a good Quality Agreement
\nWhat a Quality Agreeme nt is - and is not
\nResponsibilities of the owner v s. contract facility
\nGMP responsibilities
\n li>\nA comparison of the new guidelines from the FDA and the EU
\n\n \;
\nWho Will Ben efit:
\n\nThis webinar will provide valuable assistance to all personnel in:
\n\nQuality Assurance
\nExternal Manufacturing / Outsourcing
\nQua lity Auditing
\nTechnology Transfer
\nRegulatory Affairs / Compliance
\n \nSupply Cha in
\nPurchasing
\nRisk Managem ent
\n