Institute for International Research

cGMP for Biologics - Asia Pacific Practices & Retrospective
Tuesday, October 21, 2008 · 10:30 am - 3:30 pm

Workshop Speakers:
Ram Balani, CEO, Founder, FDASmart Inc., USA
Krishna Mukteevi, Manager, cGMP Expert Services, FDASmart Inc., USA

Workshop Objectives
Section 1: 11:00am - 11:45am
This section of the workshop will provide a quick survey of the US FDA (CFR) regulations & how US FDA inspection works to establish a baseline context for all attendees. Recent GMP related and biologics (Heparin) contamination from China and the US FDA's proposed changes towards foreign GMP inspections will be covered. Other topics include upcoming changes from US FDA ORA (Office of Regulatory Affairs) such as "Beyond the Borders" initiative and "Globalization Act of 2008", new rules of engagement with foreign GMP inspections for API, biologics, drug and medical devices manufacturers. Section 1 will end with a cGMP retrospective that will cover GMP history, practice, trends and statistics from countries in the Asia Pacific region such as India and China as well as Korea, Japan, Malaysia and Singapore.

Section 2: 11:45am - 12:30pm; 2:00pm - 3:30pm
This section of the workshop covers in detail cGMP requirements in general and those specific requirements applicable to biologicals. This section will also cover the requirements mandated under 21 CFR part 600. A specific case study where a QA system was developed for biological processing will then be discussed. The in-depth case study will trace the development of a quality system from concept on paper to the final implementation and include topics such as water purification, facility / equipment qualification etc. At the conclusion of this case study, take-away lessons to be learned include how to deal and minimize FDA 483 warning letters common to APIs and specific to biologicals and how the deviations are to be corrected through root cause analysis.

Target Audience
This workshop will be of interest to QC personnel, QA system developers and implementers at the levels of managers and senior managers working with pharmaceutical, biological or API manufacturing companies, as well as manufacturing plant site managers and senior corporate officers at pharmaceutical or biologics, medical devices and API manufacturing companies.

Schedule

Ram Balani, Acting CEO, FDASmart Inc.
Ram Balani is an experienced Information Technology and pharmaceutical industry entrepreneur/expert whose experiences include the successful delivery of outsourced clinical data management operations for the world's largest pharmaceutical company today-Pfizer Inc. via the start-up presence he established for this purpose in India in the mid-1990s.

A former Cap Gemini CIM (Computer Integrated Manufacturing) consultant, he has served in a wide variety of roles in medical research, laboratory IT (LIMS) automation, Pfizer's robotic ASRS (Automated Storage & Retrieval System), etc. The previous computer services company he founded provided information technology consulting and applications development services in the US to other pharmaceutical heavy weights such as Glaxo Smith Kline, Pfizer Inc., etc. Ram has patents pending in the US for inventing Venue Maitre'D which serve wireless hotspot suite of applications and services designed to bring location-specific information and Web 2.0 interactions.

Ram Balani is the founder-CEO of FDASmart. FDAsmart delivers US FDA regulatory intelligence and training services to the pharmaceutical and biotech industry in India and China. He is the concept developer for SmartInspect-a wearable, wireless technology used to assist cGMP plant site walk-thru or inspections. SmartInspect transmits mobile, real-time video/audio from one site to any other location via wifi 802.11b/g over Internet broadband.

Krishna Mukteevi
Mr. Krishna Mukteevi is a biotechnologist and a chemical engineer and an information technology expert by qualification. He has accumulated more than 25 years of experience in process development, scale up, technology transfer, commercial plant design and quality management. He is an accredited IS: 9000 auditor for pharmaceutical, biological and API and Food sector.

Krishna Mukteevi was also trained in software quality tools like SEI-CMM and Tick-IT. He conducted more than 100 certification audits in India and abroad apart from conducting number of audits on software quality. He has also expertise in computer system validation, network validation and system development as per 21 CFR part 11.His comprehensive understanding of GMP has been utilized at a great number of manufacturing sites to identify, document and resolve issues while providing CAPA solutions (Corrective and Preventative Actions) that cover the entire GMP regulations mandate.

He has been and continues to be presently involved in developing systems and training for cGMP related QA systems in the pharmaceutical industry Mr. Mukteevi serves as the Senior Manager for FDASmart's cGMP Expert Services Group and heads FDASmart's Training Institute's Division in Mumbai-India.

Pricing
ABLE members · 4300 INR / US$100
non-ABLE members · 15050 INR / US$350

Registration, Payment & Inquiries

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