21 CFR Part 11 Compliance 2011 - 21 CFR Part 212: Quality Systems to Ensure cGMP Compliance

Why Should You Attend:
The new GMP regulation, 21 CFR 212 “Good Manufacturing Practices for Positron Emission Tomography Drugs”, 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, “Radiopharmaceuticals for Positron Emission Tomography?Compounding.” 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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