Level: Advanced - Application
Type: Classroom Training Course
ISPE CEUs: 1.3
This course and other GMP Training is available as online training courses, 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).
SAVE hundreds of dollars on training by joining ISPE! Join now »
This course is not currently scheduled, but may be offered at your company site.
Please contact ISPE for more information.
To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.
Know Before You Go: 2016 ISPE Biopharmaceutical Manufacturing Conference
Friday, 02 Dec 2016 17.12
Sights & Bites of San Francisco – 2016 ISPE Biopharmaceutical Manufacturing Conference
Thursday, 01 Dec 2016 13.12
ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)
Wednesday, 30 Nov 2016 18.11
This course can be offered at your company site in its current format or customized to meet the needs of your organization.