BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T133451Z UID:7417d890-1f4d-40ee-b685-6c8dd1baf173 DTSTART:20201209T080000 DTEND:20201210T080000 CLASS:PRIVATE DESCRIPTION:
Course &ldquo\;2020 workshop GMP&rsquo\;s in practice: quali ty systems\, common sense compliance\, and application&ldquo\; has been Pr e-approved by RAPS as eligible for up to 6 credits towards a participant 39\;s RAC recertification upon full completion.
\n"\;Each attendee will receive 1-Day workshop materials by the speaker. Seminar Also Include s Certificate\, Complimentary Breakfast\, Lunch &\; High Tea/Coffee pro vided by WCS"\;An Interative Workshop Presented BY WCS &\; Ginette M. Collazo\, LLC.
\n\nCourse"\;GMP&rsquo\;s in practice: quality systems\, commo n sense compliance\, and application"\; has been pre-approved by RAPS as eligible for up to 6 credits towards a participant&rsquo\;s RAC recerti fication upon full completion \;
\n\nE ach attendee will receive 1-Day workshop materials \,Certificate\, Complim entary Breakfast \, Lunch &\; High Tea/Coffee provided by WCS.
\n\nThis course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also\, this course covers more than 30 elem ents of a modern quality system\, it&rsquo\;s requirements\, expectations\ , and examples. Each element is explored with applicable regulation from U S FDA\, Health Canada\, European Union WHO and ICH (for multinationals). p>\n\n
Design: \;Content based\, experiential (real
site specific examples)\, 483&rsquo\;s evaluation and Warning Letter disc
ussions. Case studies. \;
\n
\n \;
1. \; \;  \;Management and Supervision Responsi
bilities
\n2. \; \;  \;Quality Risk Management
\n3.&
nbsp\; \;  \;Knowledge Management and Organizational Learning
\n4. \; \;  \;Quality Management and Quality Systems
\n5
. \; \;  \;Product and Process Monitoring
\n6. \;&nbs
p\;  \;Discrepancy Observation and Investigation
\n7. \; 
\;  \;Complaints
\n8. \; \;  \;Qualification and Vali
dation
\n
\n \;
&bull
\; \; \;  \;Compliance officers
\n&bull\; \; \; &
nbsp\;Consultants/service providers
\n&bull\; \; \;  \;En
gineering and design control teams
\n&bull\; \; \;  \;Exe
cutive management
\n&bull\; \; \;  \;Managers
\n&bul
l\; \; \;  \;Manufacturing directors and supervisors
\n&b
ull\; \; \;  \;Procedure writers