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cGMP being the most important component in assuring pharmaceutical quality, consumers expect that each batch of medicine they consume meets the stipulated quality standard. However most of the drug manufacturers are either not aware of these cGMPs, or unaware of how FDA assures that drug manufacturing processes meet these basic objectives. This has in return resulted in the rising trend of warning letters over the past couple of years due to cGMP issues. Considering the need to address this challenge, CPhI is announcing the first ever specialised training on cGMP taking place in September at Mumbai. This two day exclusive training will be conducted by Former US F.D.A trainer who would help companies to prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.
TRAINER
Michael Goga Former Drug Specialist (Retired January 2016) USFDA
Michael served as a USFDA Investigator for 27 years with the last seven as a member of the Dedicated Foreign Drug Cadre. Over the course of his career, Michael has conducted over 500 GMPaudits of various manufacturers of FDA regulated products. Michael retired in January 2016 as a Level III Certified Pharmaceutical Inspectorate specializing in drug GMP and Pre-Approval inspections. He performed over 40 API and formulation plant inspections across India between 2005 and 2015. Michael served as an expert witness on behalf of USFDA in a civil trial in 2014. Beginning in 2016, Michael formed a consulting company providing GMP and regulatory services to the pharmaceutical industry. Michael is knowledgeable in data integrity practices; process, cleaning, and method validation; Quality Systems; GMP auditing; QC laboratory testing; instrument and equipment qualification; sterile and OSD manufacturing; Part 11- Electronic Records; HVAC and water systems; and good documentation practices.
REASONS TO ATTEND
- To gain better understanding of how the regulatory authorities look at pharma operations and to anticipate problem areas before they create problems during the inspection
- Learn from the experienced FDA expert who has been a part of various inspections and issued warning letters on cGMP
- To understand the current cGMP inspection trends in the Indian pharma companies
- To obtain current information about FDA activities
- To get your burning challenges and questions answered by the expert through an exclusive Q&A session
WHO SHOULD ATTEND?
Vice President, General Managers, Senior Managers, Managers, Executive from: Manufacturing Quality Assurance Production Quality control Engineering Tech transfer
Conference Agenda :
Data Integrity
Impact of Data integrity on GMP norms
Ways of managing and retaining GMP records
Maintaining data Integrity in laboratory and manufacturing operations
Implementation of a Data Integrity monitoring program
Quality culture
Defining the scope of quality culture
Importance of contemporaneous reporting
Good documentation practices following ALCOA
Culture related issues impacting the cGMP’s
Quality metrics to ensure the robustness of processes
How FDA intends to use quality metrics
OOS Investigations
Effective signal and trend detection
Use of quality metrics and effects of non-reporting
Reporting of quality data and calculation of quality metrics
Sanitation Practices/Pest Control/Washing and Toilet Facilities
Scope of sanitation and hygiene for personnel, premises, equipment , apparatus, production materials, containers and products
Qualification and validation of the facilities
Date : 19th - 20th September, 2016
Venue
THE WESTIN MUMBAI GARDEN CITY
International Business Park
Oberoi Garden City Goregaon East
Mumbai 400063 Maharashtra, India
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