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January 2010
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Jan 2010
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Fri, Nov 27, 2009


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• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

5
• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

6
• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

7
• How to Implement Risk Management Principles and Activities within a Quality Management System
• Auditing and Qualifying Suppliers and Vendors
• Good Monitoring Practices for Medical Devices
8
• How to Implement Risk Management Principles and Activities within a Quality Management System
• Auditing and Qualifying Suppliers and Vendors
• Good Monitoring Practices for Medical Devices
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• Advancing Biologics from the lab to the clinic
• Best Practices for an Effective Cleaning Validation Program
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
• Latin America - Understanding Regulatory Compliance Requirements
• Effective Quality Assurance Auditing for FDA Regulated Industries
12
• Advancing Biologics from the lab to the clinic
• Best Practices for an Effective Cleaning Validation Program
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
• Latin America - Understanding Regulatory Compliance Requirements
• Effective Quality Assurance Auditing for FDA Regulated Industries
• Biotech Showcase 2010
13
• PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach
• ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
• Root Cause Analysis for CAPA
• Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
• Process Validation for Drugs and Biologics
• Biotech Showcase 2010
14
• PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach
• Root Cause Analysis for CAPA
• Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
• Process Validation for Drugs and Biologics
15
• Root Cause Analysis for CAPA

16

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• FDA APPROVAL PROCESS FOR MEDICAL DEVICES

19
• FDA APPROVAL PROCESS FOR MEDICAL DEVICES
• CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010
• PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA

20
• CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010
• PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA
• EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE
• Process Validation for Medical Devices

21
• EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE
• Process Validation for Medical Devices
• Detecting Fraud and Misconduct in Clinical Trials
22
• ACTIVE COMPARATOR STUDIES
• Process Validation for Medical Devices
• Detecting Fraud and Misconduct in Clinical Trials
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• DEALING WITH DIFFICULT PEOPLE - A repeat of this successful course
• Biostatistics for Non-Statisticians
• Good Laboratory Practices (GLP) for Pre-Clinical Testing
• Validation of Computer Systems
26
• COPD & ASTHMA - AN INTRODUCTORY COURSE
• NEURO LINGUISTIC PROGRAMMING IN THE WORKPLACE
• Biostatistics for Non-Statisticians
• Good Laboratory Practices (GLP) for Pre-Clinical Testing
• Validation of Computer Systems
• World Drug Delivery and Formulation 2010
27
• THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role
• Biostatistics for Non-Statisticians
• Good Manufacturing Practices
• World Drug Delivery and Formulation 2010
28
• THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role
• BASIC PUBLICATIONS PLANNING
• MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market
• Good Manufacturing Practices
• How to Monitor Clinical Trials for GCP Compliance
29
• ADVANCED PUBLICATIONS PLANNING
• MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market
• Good Manufacturing Practices
• How to Monitor Clinical Trials for GCP Compliance
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• WORKING THROUGH DRUG DEVELOPMENT - Winter School
• Introduction to Effective Medical Writing
2
• ANNUAL CONFERENCE ON INTERNATIONAL SPORTS LAW - A Year in Sports Law
• WORKING THROUGH DRUG DEVELOPMENT - Winter School
• Introduction to Effective Medical Writing
3
• WORKING THROUGH DRUG DEVELOPMENT - Winter School
• The Drug Development Process - From Discovery to Commercialization
• Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
4
• WORKING THROUGH DRUG DEVELOPMENT - Winter School
• PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen
• The Drug Development Process - From Discovery to Commercialization
• Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
5
• WORKING THROUGH DRUG DEVELOPMENT - Winter School
• PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen
• The Drug Development Process - From Discovery to Commercialization
6

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