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Upcoming
Seminars
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1. Cleaning Validation |
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Location: Chennai
Date: October 12, 2009
Speakers: Mr. Destin LeBlanc
Time: 9:00 am. - 4:30 pm.
Upon completion of this course,the participants will be able to understand and apply:
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Principles and calculations of residue limits |
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Selection of analytical methods to measure residues |
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Selection of sampling methods |
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Determining cleaning validation acceptance criteria |
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Basics of cleaningvalidationstrategies |
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2. Fundamentals of Lyophilization |
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Location: Hyderabad
Duration: 1 day
Time: 9:00 am. - 4:30 pm.
This course is designed for participants to develop an
understanding of the basic principles and practical aspects of
Lyophilization technology. Topics covered in this course
include:
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Overview of cycles and equipment |
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Vacuum
technology used for freeze drying |
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Sublimation in primary drying |
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Desorption during secondary drying |
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Application of principles to product and process development |
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Analysis of product characteristics |
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Process scale-up to production |
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3. Pharmaceutical Stability Testing |
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Location: Chennai
Duration: 2 days
Time: 9:00 am. - 4:30 pm.
This course will survey and explore the numerous issues
concerning drug substance and drug product stability. The
relevance of the ICH Q1 series of guidelines and other sources
will be examined. Delegates will learn how to set up
scientifically sound stability protocols, generate good
stability data, learn how to evaluate it and predict shelf lives
for drug products. Topics to be covered include:
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Overview of Stability Testing |
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The
ICH and other Guidelines |
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Stability Testing for Drug Products & Substances, Stress
Testing; Existing Products and Line Extensions; Stability Plans
& Protocols; Bracket and Matrix approaches for Reduced Stability
Testing |
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Validated Analytical Methods and
Procedures |
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Evaluation of Stability Results &
Statistical Considerations; Shelf Life Prediction |
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Report
Formats CTD and Major Authority requirements |
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4. Computer Systems Validation |
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Location: Chennai
Duration: 2 days
Time: 9:00 am. - 4:30 pm.
This course outlines the importance of applying a documented and
justified risk-based approach to computer systems validation.
Participants will discuss and analyze case studies &
hypothetical systems, and have the opportunity to discuss their
own real-life validation challenges. Topics to be covered:
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Overview of Computer Systems Validation and basic concepts |
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Computer systems master validation planning |
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Planning and performing a supplier audit |
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Developing and reviewing user requirement specifications |
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Performing and documenting risk assessments |
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Developing a validation strategy and writing a validation plan |
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Writing high-quality test scripts |
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Maintaining the validated state – change control and impact
assessment |
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Regulatory hot topics |
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5. Risk based Approach Management in the Pharma Industry |
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Location: Chennai
Duration: 1 day
Time: 9:00 am. - 4:30 pm.
This course covers the regulatory and historical background to
pharmaceutical risk assessment and the use of risk assessment
and risk management tools. Attendees will solve hypothetical
problems based on real life experiences of the course tutor.
Topics covered in this seminar include:
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Overview of the risk management process and the risk assessment
tools used |
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Evaluation, control and monitoring of risk |
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Risk
related documentation & records |
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Regulatory Views and Guidelines on Risk Management |
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Analyzing and Controlling Manufacturing Process Risk Using
Failure Mode & Effects (FMEA) Analysis |
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Performing Hazard Analysis and Critical Control Point (HAACP)
Analysis |
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Practical Application of Risk Analysis to Managing CAPA
Activities |
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6. Implementation of Harmonized Compendial
Tests |
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Location: Chennai
Duration: 2 days
Time: 9:00 am. - 4:30 pm.
Dr. Dabbah and Dr. Klaus will provide perspective on the
harmonization process from the USP and EP point of views. Topics
to be covered include:
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Challenges in implementing harmonized compendial testing |
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Discussion on Microbial Enumeration Tests — USP <61>, EP, 26.12;
Tests for Specific Microorganisms-USP <62>, EP, 26.13 |
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Discussion on Acceptance Criteria for Pharmaceutical
Preparations and Substances- USP <1111>, EP, 5.1.4 |
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Panel
Discussion on Differences between USP and EP Harmonized Texts |
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Validation of Alternate Microbiological Methods, USP <1223>,
Alternate Methods for Control of Microbiological Quality, EP,
5.1.6 |
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Panel
Discussion on Harmonized Sterility Tests USP <71> , EP 2.6.1.
Differences between and USP and EP texts for Sterility Test |
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Pharmaceutical Waters USP < 1231>, EP Water Monographs |
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Clothing & Accessories
