GMP Asia Conference 2010
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Overview The pharmaceutical industry has strictly regulated environment. The core of the regulations is represented by GMP rules. These rules will outline the aspects of production that would affect the quality of the product. Tonkin’s GMP Asia Conference 2010 aims to identify the principal issues that need to be addressed to comply with GMP regulations and guidelines, describe deficiencies in GMP that may be identified by regulatory inspectors and consequences that may arise if they are not rectified, and apply principles of GMP in the manufacturing circumstances. There will also be case studies to be presented to the renown practitioners that would provide learning on how to prepare, manage and successfully complete and FDA inspections; gain comprehensive insight into the FDA’s latest expectations when conducting investigations and how to audit effectively for compliance with those expectations in mind. Event Highlights: • Increasing profit by 10% by staying competitive and compliant to the current international GMP standards this 2010 • Understanding what it takes not to have negative FDA observations to stay competitive in the pharmaceutical industry • Familiarizing with GAMP methodology for risk management to reduce liabilities by 20% • Choosing the optimum ways to deal with ICH Q10 to risk management and change control in computer validation • Mastering the EU-GMP and FDA compliance in pharmaceutical development • Mastering the writing user requirement specifications to meet FDA guidelines
Transcript of GMP Asia Conference 2010
