21 CFR Part 212: Quality Systems to Ensure cGMP Compliance - Webinar By ComplianceOnline (21 CFR Part 212)
Venue: Online Event
|Event Date/Time: Feb 11, 2011||End Date/Time: Feb 11, 2011|
The new GMP regulation, 21 CFR 212 â€œGood Manufacturing Practices for Positron Emission Tomography Drugsâ€, becomes effective on 11 December 2011 and will require all manufacturers of Positron Emission Tomography (PET) drugs to submit either a new drug application (NDA) or abbreviated new drug application (ANDA) for any PET drug product marketed for clinical use in the United States.
For PET drugs intended for clinical investigations only or for research only manufacturer have a choice to comply with either the 21 CFR Part 212 or with the current United States Pharmacopeia (USP) General Chapter 823, â€œRadiopharmaceuticals for Positron Emission Tomographyâ€“Compounding.â€ Establishing a quality system is an essential requirement for the manufacture and commercialization of all regulated products.
This webinar will discuss the requirements of the new cGMP requirements for PET drugs as compared to the USP 823 requirements, establishing an effective Quality System, the role of the Quality function in ensuring compliance, and Warning Letters associated with PET cGMP compliance.
Areas Covered in the Seminar:
Understand the differences and similarities between the General Chapter USP 823 vs 21 CFR Part 212 regulations.
The elements of an effective Quality System for the manufacture of PET drugs.
The role of Quality in assuring cGMP compliance.
Strategic advantage of a Quality and Manufacturing partnership.
Key cGMP Issues from PET Regulatory Authority Inspections.
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