Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Systems-Based Inspection Approach To Be Expanded By Early 2002

Executive Summary

FDA's systems-based inspection program could be expanded nationwide at the beginning of 2002, CDER Office of Compliance Division of Manufacturing & Product Quality Director Joseph Famulare told the Regulatory Affairs Professionals Society meeting in Baltimore, Md. Nov. 6

You may also be interested in...



Therapeutic Biologic GMP Inspections To Become “More Systems-Based”

Therapeutic biologics manufacturing compliance inspections will move toward the systems-based approach used by the Center for Drug Evaluation & Research, Office of Regulatory Affairs Regional Operations Director Deborah Ralston said

Therapeutic Biologic GMP Inspections To Become “More Systems-Based”

Therapeutic biologics manufacturing compliance inspections will move toward the systems-based approach used by the Center for Drug Evaluation & Research, Office of Regulatory Affairs Regional Operations Director Deborah Ralston said

FDA GMP Plan Stresses Consistency; Systems Approach Ratified By Crawford

FDA will work with an outside consultant to help increase the consistency of pre-approval and post-approval manufacturing oversight

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS038860

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel