COURSE OBJECTIVE:
To provide an understanding of the GMP Audit Policy, Audit preparation, Audit Conduct and Audit follow-up along with Internal First Party, Second Party and Third Party Audits.
DESCRIPTION AND OUTLINE:
GMP general considerations and definitions, requirements for activities of manufacturing / fabrication, packaging / labelling, testing, importing and distribution (as per USFDA)
CFR 21 Parts related to finished formulations and API, Good laboratory practice GLP for non clinical laboratories, introduction to TGA(Australia), HPFBI(Canada), SDFA(China), MCC(South Africa)
Schedule - M: Facility, equipment, personnel, manufacturing, quality control & quality assurance requirements for manufacturing of Sterile, non-sterile finished pharmaceuticals and active pharmaceutical ingredients
GMP compliance audit definition and definition summary, audit policy, internal audits, external second party audits, external third party audits, preparation for audit, conducting audit, audit analysis, audit report, audit follow-up, a typical internal (first party) audit report, external (second party) audit report, third party audit report
COURSE FEATURES:
DURATION:
4-5 Hours a Day twice a week for about 7-8 weeks
(On Saturdays & Sundays to suit the working professionals / Industry)
MODE OF DELIVERY:
The total Study Material will be provided at the beginning of the course itself.
Direct Interaction with Subject Matter experts
4-5 Weeks of Class room Study
1-2 Weeks of Practical Exposure
1 Week for summing up
DURATION:
4 Hours a week for about 12 weeks
(Preferably in early Mornings & Evenings on Saturdays & Sundays)
MODE OF DELIVERY:
Total Study Material will be provided at the beginning of the course itself.
Online Interaction with Subject Matter experts through webinars
