IDMA Technical, R&D and QA Sub-committee and Association of Pharmaceutical Analysts (APA) are organising a one-day seminar on “Regulatory Perspective for Microbial Control” on Saturday, May 29, 2004 at Sunville Banquet Rooms, Atop Barista Coffee Shop, 9, Dr Annie Besant Road, Worli, Mumbai.
Experts in the fields of sterile operations and bioprocessing equipments and methods would share their information on subjects which need to be discussed in the context of pharma companies going in for FDA/MCA approvals.
The seminar will address issues and topics like-- the regulatory requirements and expectations for microbiological studies/testing in a regular manufacturing set-up; approaches acceptable for microbiological & sterility testing; the best approach for various potential/sterile/aseptically processed products in microbiological angles; aspects of specific quantitative limit in microbial testing.
Personnel from QC/QA, regulatory, microbiology, engineering and biopharmaceutical sections will benefit from the deliberations.
The registration fee for the Seminar is Rs. 1000/- per person (For IDMA/APA/PEG members) to defray the expenses towards lunch, tea/coffee and seminar material. For non-IDMA/APA/PEG members, the registration fee will be Rs.1200/-per person, an official release said.