GMP UPDATE 2005 - June 6-7, 2005 - Toronto, Canada - Lyophilization Conferences 2005

GMP UPDATE 2005
June 6-7, 2005 - Toronto, Canada
Hilton Toronto Airport Hotel
This important event promises to deliver the most valuable, multi-leveled conference, offered to pharmaceutical, biopharmaceutical, medical devices and allied industries. It will address compelling issues and the latest changes in GMP regulations and requirements.
This event hosts both national and international eminent expert presenters from; Food and Drug Administration (FDA) CDER, Health Canada BREC and HPFBI, United Kingdom?s MHRA, European Generic Medicine Association EGA, ICH Steering Committee, WHO Expert Committee, and executive industry professionals.
In today?s global market where the globalization of the drug product plays an essential role in companies? growth and survival, drug manufacturers need to adhere to more demanding standards of GMP imposed by various regulatory agencies. Their products can then meet the approval of major European, North American and other markets. This means companies have to conform to the required specification and ensure that inspections and approvals of their products by all major regulatory authorities are done in a coordinated way and in accordance with current GMP requirements.
This conference will address the implications of what the current key GMP requirements are and how are they changing, or interpreted by various regulatory agencies. The program content is designed and based on the FDA?s revised Good Manufacturing Practices (GMPs) guidelines, WHO new initiatives on GMP, ICH Q7, European Legislation on API manufactures, Health Canada's Pre-Approval inspection process for biologics and many other pressing issues.
The ?GMP UPDATE 2005? is the place to be for an unparalleled learning experience and networking opportunities.
This unique event will keep the delegates abreast of the recent developments and give each individual ample opportunities to meet and ask detailed questions from regulatory representatives, who provide you with an understanding of a new direction in Pharmaceutical and biological regulatory activities.
Program Highlights
FDA recent guidance published relating to the GMP program
FDA future guidance documents and those under revision
Current guidance and standards for API manufacture
New EU legislation impacting API manufacture
EU Guide to GMP ? Annex 18
MHRA Voluntary Inspection Program
New requirements for Establishment License Application - Health Canada
Investigational Medicinal Products (IMP) Inspections
Patent system and regulatory requirements in EU
GMPs for Biologics - Health Canada
ICH Regulatory frame work in Q7A
Implementation of Q7A in Canada for Biologics
Health Canada's Pre-Approval inspection process for biologics
cGMP during Biopharmaceutical Development
WHO New revised GMP guidelines
GMP for HVAC systems
GMP Supplementary text on Validation
GMP: Water for Pharmaceutical Use
Sampling of Pharmaceuticals and related materials
Good Distribution Practices (GDP) for pharmaceutical products
FDA's system based approach to inspection
FDA's Update on the Risk-based Site Selection model for inspections
Temperature Control of Drug Products during Storage and Transportation - Health Canada
Post-Market Reporting Compliance - Health Canada
Standard for the fabrication, control and distribution of anti-microbial agent
GMP Compliance for Vaccines