BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T093956Z UID:c2c93116-bfbc-497a-9c53-b243135a3a0d DTSTART:20201211T083000 DTEND:20201212T083000 CLASS:PRIVATE DESCRIPTION:\n
One of the fundamental concepts of &ldquo\;current Good Manufac turing Practices&rdquo\; (cGMP) is that companies that manufacture and/or test medicines should be in a constant &ldquo\;State of Control&rdquo\;\; in other words the medicines produced should have pure raw materials\, app ropriate equipment\, cleanliness\, trained personnel\, accurate testing an d everything documented from first to last.
\n\nThis &ldquo\;State of Control&rdquo\; is achieved by havi ng a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990&rsquo\;s the US FDA\, the European Agencies and Japan began an effort to standardize regulator expe ctations for cGMP manufacturing. This culminated in a series of Quality Gu idances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12 ) define the high level expectation for maintaining a State of Control.
\n\nThis course will cover those ICH Guidances related to the Quality Systems for manufacturing:
\nIn addition certain aspects of the US FDA&rsquo\;s and EMA&rsquo\;s laws will also be covered:
\n\nAs data int egrity has become a &ldquo\;hot&rdquo\; topic and a frequent observation b y regulators\, one session will be devoted to Data Integrity in both manua l and automated systems.
\n\nUS FDA\, MHRA
\, EMA\, Japan all have an extremely high expectation that manufacturers a
nd testing labs who sell and/or test products for their markets will confo
rm to the requirements for having a &ldquo\;State of Control&rdquo\;. This
state will be evaluated by inspectors to determine that the Quality Syste
ms are in place and that the Quality Management is able to maintain discip
line and provide documentary evidence that a State of Control exists.
\nInadequate Quality Systems and/or Quality Management are a guaranteed p
ath to receiving an Import Alert\, Warning Letter and/or EU Non-compliance
Report.
A small investment to ensure the GMP workforce\, especially Quality Unit Management\, is ful ly in control of the Quality Systems is excellent insurance to avoid regul atory action that can have a negative market impact on the company and pot entially huge cost for remediation.
\n\nIn this two day workshop conference you will learn what global re gulators expect for Quality Systems\, Quality Management and a State of Co ntrol. During the workshop we will analyze case studies and perform class activities to better understand both theory and some practical approaches to Quality Management.
\n \;\n\nUpon completing this course participants should:
\n\nThis course is designed for people throughout the GMP Operations with a focused emphas is on the Plant &\; Global Quality Units\; Departmental Heads\, Manager s &\; Supervisors\; and Plant Management. In addition\, all GMP operati ons personnel could benefit\, especially those selected SMEs within the or ganization who will face the inspectors.
\n\nFollowing personnel will benefit from the course:
\n\n