Biotech China 2014
IVT 's Lab Week
Catamaran Resort Hotel
3999 Mission Boulevard
San Diego, CA
http://www.labweekevent.com/

Schedule of Presentations:

Tuesday, October 2, 2007
07:30:00 Conference Registration and Continental Breakfast
08:30:00 HPLC Method Development | Session 1 LC Method Development with Validation in Mind Michael Swartz
08:30:00 Preparing Vendor Receiving Laboratory for Analytical Method Transfer | Session 2 Successful Analytical Method Transfer in a Pharmaceutical Virtual Environment James K MacNamara
08:35:00 Method Transfer Protocol | Session 2 Successful Analytical Method Transfer in a Pharmaceutical Virtual Environment James K MacNamara
08:40:00 Protocol Execution | Session 2 Successful Analytical Method Transfer in a Pharmaceutical Virtual Environment James K MacNamara
08:40:00 Method Validation Pertaining to HPLC | Session 1 LC Method Development with Validation in Mind Michael Swartz
08:45:00 Final Executed Protocol/Transfer Report | Session 2 Successful Analytical Method Transfer in a Pharmaceutical Virtual Environment James K MacNamara
08:50:00 Interactive Exercise | Session 1 LC Method Development with Validation in Mind Michael Swartz
08:50:00 Interactive Exercise | Session 2 Successful Analytical Method Transfer in a Pharmaceutical Virtual Environment James K MacNamara
09:45:00 Development Experiments for Method Capacity | Session 4 When is a Method Ready to Move from Development to Validation? Timothy Grosch
09:45:00 Validating Analystical Procedures for Drugs | Session 3 Validation/Verification of Compendial Procedures Eric B Sheinin
10:05:00 Post Development and Pre-Validation Experimentation | Session 4 When is a Method Ready to Move from Development to Validation? Timothy Grosch
10:05:00 Verifying Analytical Procedures for Drugs | Session 3 Validation/Verification of Compendial Procedures Eric B Sheinin
10:25:00 Interactive Exercise | Session 3 Validation/Verification of Compendial Procedures Eric B Sheinin
10:25:00 Interactive Exercise | Session 4 When is a Method Ready to Move from Development to Validation? Timothy Grosch
11:00:00 Method Validation and the State of Outsourcing | Session 6 The Role of the Contract Lab in Test Method Validation Jon Brice
11:00:00 Developing the Scope of a Comprehensive Remediation Program | Session 5 Get Well - Stay Well: Change Control, Annual Product Review and Remediation of Test Method Validations Joe Fosco
11:10:00 Finding, Evaluating, and Retaining a Contract Laboratory for Analytical Development | Session 6 The Role of the Contract Lab in Test Method Validation Jon Brice
11:15:00 Get Well | Session 5 Get Well - Stay Well: Change Control, Annual Product Review and Remediation of Test Method Validations Joe Fosco
11:20:00 Starting Off on the Right Foot - Protocols | Session 6 The Role of the Contract Lab in Test Method Validation Jon Brice
11:30:00 The Mechanics of Validation | Session 6 The Role of the Contract Lab in Test Method Validation Jon Brice
11:30:00 Stay Well | Session 5 Get Well - Stay Well: Change Control, Annual Product Review and Remediation of Test Method Validations Joe Fosco
11:40:00 Interactive Exercise: Launching a Validation Project | Session 6 The Role of the Contract Lab in Test Method Validation Jon Brice
11:45:00 Measure and Monitor | Session 5 Get Well - Stay Well: Change Control, Annual Product Review and Remediation of Test Method Validations Joe Fosco
12:00:00 Lunch
13:00:00 Chairperson's Welcome and Opening Remarks General Session Michael Swartz
13:10:00 A Validation Master Plan for Test Method Validation Projects General Session Michael Swartz
14:00:00 A Primer on Potent Compounds Cleaning Methods for Potent Compounds - Validation Considerations Jon Brice
14:10:00 Handling of Potent Compounds Cleaning Methods for Potent Compounds - Validation Considerations Jon Brice
14:20:00 Validation of Cleaning Methods Cleaning Methods for Potent Compounds - Validation Considerations Jon Brice
14:30:00 Potents - Now You Must Clean More Than the Reactor! Cleaning Methods for Potent Compounds - Validation Considerations Jon Brice
14:45:00 Refreshment Break
15:00:00 Challenges in Meeting the Regulatory Requirements for Method Validation General Session Eric B Sheinin
15:45:00 Performing Validation Under Time and Budget Pressure General Session Timothy Grosch
16:30:00 From Development to Market: How Much Validation is Enough? Panel Discussion Michael Swartz
17:00:00 Close of Day One
18:30:00 Networking Dinner and Entertainment Cruise
Wednesday, October 3, 2007
07:30:00 Conference Registration and Continental Breakfast
08:00:00 HPLC Equipment Qualification | Track B Building a Compliant Laboratory Strategies for HPLC (High Performance Liquid Chromatography) Lifecycle Validation Iris Unterrieder
08:00:00 FDA's expectation for raw data | Track D Compliant Data & Documentation for the Laboratory Raw Data in the Laboratory: Definition, Maintenance, Archiving Ludwig Huber
08:00:00 Laboratory Audits: The Basics | Track R Regulatory Compliance in the Laboratory Laboratory Inspections: The Nuts and Bolts Approach Anne Garstka
08:35:00 Computerized System Qualification | Track B Building a Compliant Laboratory Strategies for HPLC (High Performance Liquid Chromatography) Lifecycle Validation Iris Unterrieder
09:10:00 HPLC Method Development | Track B Building a Compliant Laboratory Strategies for HPLC (High Performance Liquid Chromatography) Lifecycle Validation Iris Unterrieder
09:10:00 Maintenance, Archiving, and Retrieval of Electronic Raw Data | Track D Compliant Data & Documentation for the Laboratory Raw Data in the Laboratory: Definition, Maintenance, Archiving Ludwig Huber
09:10:00 Preparing Your Site for Inspection | Track R Regulatory Compliance in the Laboratory Laboratory Inspections: The Nuts and Bolts Approach Anne Garstka
09:45:00 HPLC Method Validation | Track B Building a Compliant Laboratory Strategies for HPLC (High Performance Liquid Chromatography) Lifecycle Validation Iris Unterrieder
10:20:00 Interactive Exercise | Track R Regulatory Compliance in the Laboratory Laboratory Inspections: The Nuts and Bolts Approach Anne Garstka
10:20:00 Case Studies from Laboratories and Office Applications | Track D Compliant Data & Documentation for the Laboratory Raw Data in the Laboratory: Definition, Maintenance, Archiving Ludwig Huber
10:20:00 Validation Maintenance | Track B Building a Compliant Laboratory Strategies for HPLC (High Performance Liquid Chromatography) Lifecycle Validation Iris Unterrieder
11:30:00 Lunch
12:30:00 The Tools for Detecting Trends | Track D Compliant Data & Documentation for the Laboratory Finding Trends in Analytical Release Data: How to Detect and How to React Michael Nolchen
12:30:00 Stability Programs Regulatory Requirements | Track B Building a Compliant Laboratory Regulatory Compliance in the Stability Lab Yin Jiang
12:30:00 FDA and International Requirements | Track R Regulatory Compliance in the Laboratory The Self Audit: Assessing Laboratory Compliance Anne Garstka
12:45:00 Type of Stability Studies | Track B Building a Compliant Laboratory Regulatory Compliance in the Stability Lab Yin Jiang
13:00:00 Interactive Exercise | Track D Compliant Data & Documentation for the Laboratory Finding Trends in Analytical Release Data: How to Detect and How to React Michael Nolchen
13:00:00 Trend Analysis in QC of Marketed Products | Track D Compliant Data & Documentation for the Laboratory Finding Trends in Analytical Release Data: How to Detect and How to React Michael Nolchen
13:00:00 Batch Selection, Interval, and Storage Condition | Track B Building a Compliant Laboratory Regulatory Compliance in the Stability Lab Yin Jiang
13:00:00 Performing a Laboratory Assessment | Track R Regulatory Compliance in the Laboratory The Self Audit: Assessing Laboratory Compliance Anne Garstka
13:30:00 Interactive Exercise | Track B Building a Compliant Laboratory Regulatory Compliance in the Stability Lab Yin Jiang
13:30:00 Follow-up of the Assessment | Track R Regulatory Compliance in the Laboratory The Self Audit: Assessing Laboratory Compliance Anne Garstka
13:30:00 Interactive Exercise | Track D Compliant Data & Documentation for the Laboratory Finding Trends in Analytical Release Data: How to Detect and How to React Michael Nolchen
14:00:00 Refreshment Break
14:30:00 FDA Keynote Presentation: FDA's Final OOS Guidance Paul Haynie
15:30:00 Day Two Chairperson's Opening Remarks Genera Session Gaurav Walia
15:35:00 Current FDA 483s and Warning Letter Trends With an Emphasis on Industry Case Studies: Are Your Data and Documentation Practices Good Enough? Panel Discussion Gaurav Walia
16:15:00 Panel Discussion and Q&A Session with Speakers Gaurav Walia
17:00:00 Close of Day Two
Thursday, October 4, 2007
08:00:00 Continental Breakfast
08:30:00 Components of Data Quality | Track R Regulatory Compliance in the Laboratory Implementing Analytical Instrument Qualification According to the New USP Draft <1058> Iris Unterrieder
08:30:00 Regulations and Guidance Overview | Track D Compliant Data & Documentation for the Laboratory Proper Design and Maintenance of a GMP Training Program Gaurav Walia
08:30:00 cGMP Regulations | Track B Building a Compliant Laboratory cGMP (Current Good Manufacturing Practice) Testing int he Quality Control (QC) Laboratory Yin Jiang
09:10:00 State of Control | Track B Building a Compliant Laboratory cGMP (Current Good Manufacturing Practice) Testing int he Quality Control (QC) Laboratory Yin Jiang
09:10:00 Training SOPs | Track D Compliant Data & Documentation for the Laboratory Proper Design and Maintenance of a GMP Training Program Gaurav Walia
09:20:00 Qualification Phases: DQ, IQ, OQ, PQ | Track R Regulatory Compliance in the Laboratory Implementing Analytical Instrument Qualification According to the New USP Draft <1058> Iris Unterrieder
09:50:00 Lean Lab | Track B Building a Compliant Laboratory cGMP (Current Good Manufacturing Practice) Testing int he Quality Control (QC) Laboratory Yin Jiang
09:50:00 Who Carries out the Training | Track D Compliant Data & Documentation for the Laboratory Proper Design and Maintenance of a GMP Training Program Gaurav Walia
10:10:00 Special Considerations | Track R Regulatory Compliance in the Laboratory Implementing Analytical Instrument Qualification According to the New USP Draft <1058> Iris Unterrieder
10:30:00 Lab Operational Excellence | Track B Building a Compliant Laboratory cGMP (Current Good Manufacturing Practice) Testing int he Quality Control (QC) Laboratory Yin Jiang
10:30:00 Training Documentation and Maintenance Proper Design and Maintenance of a GMP Training Program Gaurav Walia
11:00:00 Interactive Exercise | Track R Regulatory Compliance in the Laboratory Implementing Analytical Instrument Qualification According to the New USP Draft <1058> Iris Unterrieder
11:10:00 Interactive Exercise | Track B Building a Compliant Laboratory cGMP (Current Good Manufacturing Practice) Testing int he Quality Control (QC) Laboratory Yin Jiang
11:10:00 Interactive Exercise | Track D Compliant Data & Documentation for the Laboratory Gaurav Walia
12:00:00 Lunch
13:30:00 Status of the ICH Quality Documents | Track R Regulatory Compliance in the Laboratory 21 CFR Part 820 and ICH Q8, Q9, Q10: The Changing Face of Quality Anne Garstka
13:30:00 Getting to Know Your COTS System | Track B Building a Compliant Laboratory Ensuring that COTS System are Suitable Bryan Hunt
13:30:00 Definition of Different Kinds of Biological Standards | Track D Compliant Data & Documentation for the Laboratory Establishment of Different Kinds of Biological Standards Iris Unterrieder
13:45:00 Production of a Biological Reference Standard | Track D Compliant Data & Documentation for the Laboratory Establishment of Different Kinds of Biological Standards Iris Unterrieder
13:50:00 Key Elements in Risk Management | Track B Building a Compliant Laboratory Ensuring that COTS System are Suitable Bryan Hunt
14:00:00 Potency Assignment | Track D Compliant Data & Documentation for the Laboratory Establishment of Different Kinds of Biological Standards Iris Unterrieder
14:00:00 Develop a Fresh Approach to Quality Systems | Track R Regulatory Compliance in the Laboratory 21 CFR Part 820 and ICH Q8, Q9, Q10: The Changing Face of Quality Anne Garstka
14:10:00 Applying the Risk Based Approach & Knowing What to Test | Track B Building a Compliant Laboratory Ensuring that COTS System are Suitable Bryan Hunt
14:15:00 Maintenance of Biological Reference Standard | Track D Compliant Data & Documentation for the Laboratory Establishment of Different Kinds of Biological Standards Iris Unterrieder
14:30:00 Interactive Exercise | Track R Regulatory Compliance in the Laboratory Anne Garstka
14:30:00 Interactive Exercise | Track D Compliant Data & Documentation for the Laboratory Iris Unterrieder
14:30:00 Interactive Exercise | Track B Building a Compliant Laboratory Bryan Hunt
15:00:00 Break
15:30:00 Day Three Chairperson's Opening Remarks General Session Ludwig Huber
15:35:00 Applying Risk Management to the Verification of Standard Methods General Discussion Ludwig Huber
16:15:00 Panel Discussion and Q&A Session with Speakers Panel Discussion Ludwig Huber
17:00:00 Close of Day Three
Friday, October 5, 2007
07:30:00 Registration and Continental Breakfast
08:00:00 Regulatory Considerations for Stability Testing FDA Keynote Presentation Barry Rothman
09:00:00 The Evolution of Risk Management within the Industry | Session 7 Risk Management in Stability Operations John O'Neill
09:00:00 Requirements Definition | Session 8 Compliant Stability Data Management, Defining the Requirements Susan Cleary, Parsa Famili
09:15:00 Defining all Common Terms | Session 7 Risk Management in Stability Operations John O'Neill
09:20:00 Writing Requirements Keeping Validation in Mind | Session 8 Compliant Stability Data Management, Defining the Requirements Susan Cleary, Parsa Famili
09:30:00 Run through the Formula and Calculations | Session 7 Risk Management in Stability Operations John O'Neill
09:40:00 Finalizing the System | Session 8 Susan Cleary, Parsa Famili
09:45:00 Identify the Most Common Areas of Risk in the Stability Realms | Session 7 Risk Management in Stability Operations John O'Neill
10:00:00 Interactive Exercise | Session 8 Compliant Stability Data Management, Defining the Requirements Parsa Famili, Susan Cleary
10:00:00 Interactive Exercise | Session 7 Risk Management in Stability Operations John O'Neill
10:30:00 Refreshment Break
10:45:00 FDA Requirements for Handling OOS/OOT Results | Session 9 Case Study: Out -of-Specification (OOS) Investigations for Stability Samples Nanda K Subbarao
10:45:00 The Purpose of Stability Testing | Session 10 Stability Testing - Scientific Principles & Regulatory Considerations Satyam Upadrashta
11:00:00 Science Behind the Study Design - Session 10 Stability Testing - Scientific Principles & Regulatory Considerations Satyam Upadrashta
11:05:00 How to Perform OOS Investigations | Session 9 Case Study: Out -of-Specification (OOS) Investigations for Stability Samples Nanda K Subbarao
11:15:00 Regulatory Considerations | Session 10 Stability Testing - Scientific Principles & Regulatory Considerations Satyam Upadrashta
11:25:00 How to Deal with the OOS Data | Session 9 Case Study: Out -of-Specification (OOS) Investigations for Stability Samples Nanda K Subbarao
11:30:00 Stability Principles | Session 10 Stability Testing - Scientific Principles & Regulatory Considerations Satyam Upadrashta
11:45:00 Interactive Exercise - Case Studies | Session 10 Stability Testing - Scientific Principles & Regulatory Considerations Satyam Upadrashta
11:45:00 Interactive Exercise Case Study | Session 9 Case Study: Out -of-Specification (OOS) Investigations for Stability Samples Nanda K Subbarao
11:45:00 Examine Root Causes of Documentation Deficiencies | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
12:15:00 Lunch
13:15:00 Refurbish Your Gray-Matter with Good Documentation Principles | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
13:15:00 Qualifying a Chamber from Start to Finish to Remain in Compliance | Session 11 Chamber Temperature and RH Mapping Patrick Bell
13:30:00 Documentation-Related 483s | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
13:45:00 Examine Root Causes of Documentation Deficiencies | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
13:45:00 Conducting the Pre- and Post Qualification Studies | Session 11 Chamber Temperature and RH Mapping Patrick Bell
14:00:00 Challenge your Checklist of Stability-Related Documents | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
14:15:00 Interactive Exercise | Session 11 Chamber Temperature and RH Mapping Patrick Bell
14:15:00 Put Documentation in your Objectives and on your Performance Appraisal | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
14:30:00 Interactive Exercise | Session 12 Closing the Documentation Window of Opportunity for Stability Auditors John O'Neill
14:45:00 Refreshment Break
15:00:00 Chairperson's Opening Remarks General Sessions Barry Scheer
15:05:00 Building Science into Stability Studies General Session Yan Wu, Barry Scheer
15:45:00 Integrate Laboratory Information Management Systems (LIMS) to Optimize Stability Programs General Session Patrick Bell
16:30:00 Panel Discussion: Capturing Science into the Understanding/Prediction of Stability Data Panel Discussion Barry Scheer
17:00:00 Close of Conference
4th Annual Pharma R&D Asia Congress
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