Level: Advanced - Application
Type: Classroom Training Course
ISPE CEUs: 1.3
This course and other GMP Training is available online training courses. Visit USFDA GMP Inspection Approach.
The highly interactive course uses extensive exercises to provide an intense examination and interpretation of the cGMP regulations with special emphasis on applying the "right dose" of GMP to various situations to assure that methods, facilities, and controls are used for the manufacture processing, packing, or holding of drug products to meet requirements for safety, identity, strength, quality, and purity. The regulation will be divided into six elements: materials, buildings, equipment, records, procedures, and people. Participants will focus on compliance strategies for interpreting the controls needed to continuously operate in a state-of-control, validation, cleaning, and training interpretations will be discussed throughout. Specific case studies will be evaluated by the participants while the concept of regulatory inspections is covered along with an examination of the USFDA's quality system inspection techniques and the European inspection practices. Special emphasis will be placed on both cGMP compliance cGMP performance issues. Note: We recommend attendees have a least two years of experience with the cGMPs to attend this course.
This training course is of particular interest to existing and future members of the ISPE Process/Product development Community of Practice (COP).
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This course can be offered at your company site in its current format or customized to meet the needs of your organization.