2day Inperson Seminar on Validations and Resolving Problems Related to Them at Mumbai
This course is designed for people who are growing in their knowledge of pharmaceutical industry practices and regulations. It will be a "how to" course where the instructors will explain the reasoning as well as the procedures that should be used to meet the various requirements of pharmaceutical regulations as they are applied to validations. The instructors will present different areas of study and present them with a "how to" approach so that the seminar participant can see how the subject matter applies to the participant's work either now or in the future. In addition to discussing the particular subjects they will explain how pharmaceutical regulatory requirements can be met when conducting the work. Each instructor has decades of experience in working with and within the regulated pharmaceutical industry in the US. They will be covering topics that they are familiar with and will present them in a manner aimed at workers who may have been introduced to basic pharmaceutical practices and regulations, and now wish to expand their knowledge base.
Why should you attend?
Any pharmaceutical worker, who performs, supervises or reviews development and manufacturing processes needs to develop a full understanding of validations and the methods for performing validation studies. This is particularly true for workers in Regulatory Affairs, Quality Control and Quality Assurance as many of the required studies and their documentation will be assigned to them. All workers who supervise or execute development and manufacturing processes should have a firm understanding of pharmaceutical validations and their regulatory requirements as these will become a routine part of pharmaceutical development and manufacturing for all types of medicinal products, and must become a part of the body of knowledge possessed by senior workers.
Who Will Benefit:
• Supervisors, and lead workers in Product and Process Development
• Regulatory Affairs
• Quality Assurance and Quality Control
• Workers who will be participating in operations or the supervision of the development
• Manufacturing or testing of medicinal products will benefit from knowing the procedures and applications of various areas of pharmaceutical regulations.
Lecture 1: Development and Effective Implementation of a Cleaning Validation Program.
• FDA Requirements and Industry Standard Practices
• How to review your cleaning procedures - selection of cleaning agents and parameters
• How to Develop a Cleaning Validation Policy/Program
• How to Develop a Cleaning Validation Plan
• Information required
• Analytical Method development and validation
• How to select challenge conditions and determine acceptance criteria application of a matrix approach, worst case selection, determination of the sampling plan and limit calculations
Lecture 2: Regulatory Hot Topics related to Cleaning Validation
• Documentation requirements - protocols and reports
• Calculation of Residual Limits
• Execution of the CV protocols, reporting of results and handling of deviations
• Holding Times
• Campaign Challenge
Lecture 3: Other Regulatory Hot Topics
• Monitoring and Change Control
• Cleaning validation deficiencies observed by the regulatory inspectors
• The Future of cleaning and cleaning validation
Lecture 4: Pharmaceutical process validation lifecycle approach
• Historical Background
• The three phases of the Process Validation Lifecycle:
• Process Design,
• Process Qualification (Confirm) and Continued Process Verification (Monitor and Assess)
• The pharmaceutical development process - identify and control the critical sources of variation
• Application of Risk Management and QbD Principles
Lecture 5: Continued Process Verification - how to monitor, analyze the data and implement changes to achieve continuous improvement.
• Effective Technology Transfer
• Knowledge Management
• Implementation - Process Validation Policy
• Selection of characteristics to monitor and sampling frequency and quantity
• Selection of tools to analyze data and frequency of analysis
Lecture 6: Regulatory Hot Topics related to Cleaning Validation
• How to determine actions as a result of the analysis to achieve process improvements
• Application to existing processes
• Legacy products and processes.
Lecture 7: Overview of Problem Solving and Investigation methods.
• Brain storming and writing.
• Decision making with Designed Experiments.
• Cause and effect, Fishbone, and Ishikawa Diagrams
• Fault Tree Analysis and Failure Modes and Effects Analysis
• HU and TRIZ
Lecture 8: Brain Storming and Writing
• What are the problems? The good, the bad, and the ugly.
• Effective procedures. All is not lost.
About Speaker: Dr. Steven S. Kuwahara Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.
DATE, VENUE & PRICE:
Location: Mumbai | November 11th & 12th, 2013 | 9 AM to 6 PM
Venue: The LaLiT Mumbai
Sahar Airport Road, Andheri East, Mumbai - 400059
Price: Rs 18,000
Register now and save 2000 (Early Bird)
Until October 10, Early Bird Price: Rs 18,000.
From October 11 to November 10, Regular Price: Rs 20,000.
Toll free: 1800 425 9409
Phone number: +91 80-3201-4957 / +91 80-3247-3696
FAX: +91 080-25149544
Event Link - http://bit.ly/1b1EkbK
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Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
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