March 23-24, 2010 | Somerset, NJ - USA

Conference Topics

• Regulatory Requirements for Stability Testing - FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
• Stability Studies and the Product Life Cycle
• Update on the WHO Stability Guideline
• How to Calculate Product Expiry after Excursions
• Designing and Implementing an Effective Commercial (Marketed products) Stability Program
• Requirements for Stability Testing - API and Formulation Impurities
• Stress Testing of APIs and Drug Products
• Stability Indicating Profile for Biotechnology Products: Considerations for Development of Stability Testing Program for Biopharmaceuticals
• Vaccine Shelf Life and Post-licensure Stability Studies
• Implementation of the WHO Guideline on Stability Evaluation of Vaccines
• The Methodology for calculating Stability and Release Limits
• Setting Specifications for Drug Products
• Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs
• Quality by Design (QbD) and Stability Testing
• Q1E – ICH Harmonised Tripartite Guideline – Evaluation for Stability Data
• Using Practical Statistics to Interpret Stability Results
• Stability Challenges of Biologics
• Forced Degradation Studies Predict Effects on Bio-products in Drug Development and Manufacture
• Use of Statistics to Establish a Stability Trend – Matrixing & Bracketing
• Stability Testing in Challenging Storage Environments
• Stability Challenges of OTCs, Nutraceuticals and Combination Products
• Post Marketing Stability Evaluation
• Evaluating Product Quality After a Temperature Excursion

April 14-15, 2010 - Montreal, Canada

Identify opportunities to improve your internal audit activity's ability to add value and improve operations - and develop actions to move forward on the path to quality

This two-day "hands on" training course & workshops will address various topics, techniques, tools and methods for auditing including:

• Audit Standards
• Auditing to U.S. drug (21CFR Part 210/211) and device (21CFR Part 820) good manufacturing practices and the QSR 
• Auditing to European Union directives
• Auditing to ISO Standards
• Role Characteristics of the Auditor
• Auditing Techniques 
• The Audit Process 
• Audit Mechanics 
• Requirements of the Standard Being Audited
• Internal Facility Audits
• External Audits
• Product, process, procedural and system audits
• Auditing Packaging and labeling system
• Auditing Laboratory Control System
• Evaluate Audit Results
• Preparing Audit Reports results
• What makes a Good Audit

March 24 - 25, 2010 | Toronto, Canada

A Two day comprehensive course with workshops on:

• Annual Product Quality Review (APQR) - Interpret Health Canada’s regulatory requirements
• US FDA CFR 211, § 211.180
• ICH Annual Review Content
• Product Quality Review (EU GMP Guide)
• Annual Product Quality Review, AQPR (Canadian GMP) Vs. Annual Product Review (US, FDA)
• Developing Standard Operating Procedures (SOPs) - What should be included
• Best Practices for Writing AQPR Reports
• Proposed Chapters of a Product Quality Review (PQR)
• Documentation for APRs - Format and Methods of APR Documentation
• Implementing Best Practices for Writing Annual Reports
• Overview for CMC Section of Annual Reports
• CMC Section Table of Contents
• Quality-by-Design (QbD) paradigm and Annual Product Quality Review, (APQR) and Annual Reports (AR) 

April 14-15, 2010 - Montreal, Canada

Featuring In-Depth Presentations, Case-Studies & Workshops on:

• Regulatory Expectations
• Perspective from the FDA: 21 CFR Part 11 Compliance and Computer Validation
• Determine Which Systems Need to be Validated
• Software Validation Requirements for:
• Spreadsheets
• Production Equipment
• Lab Equipment
• Data Migration
• User Requirement Specifications (URS)
• Design Specifications
• Compiling the Validation Master Plan (VMP)
• Qualification Requirements (IQ,OQ, PQ)
• Preparing Validation Summary Reports
• Requirements for Off the Shelf (OTS) Software
• Validation Planning and Project Management
• Effective Software Testing
• Auditing GxP Computer Systems
• Auditing Software Vendors
• Assessing the Impact of Software Changes

Workshop

• System Retirement
• Auditing GxP Computer Systems

Interactive Exercises

• Performing a Self Audit of GxP Computer Systems for your Site
• Participants will review of a variety of scenarios, and using the given templates and questionnaires will evaluate the pros and cons

March 30-31, 2010 - Somerset, NJ, USA

A Two-day interactive course with workshops, case studies and Interactive exercises on:

• Risk Management Basics
• The ISO 31000 global risk management process model
• Current Risk Management initiatives (ICH, FDA, ISO etc.) and regulatory expectations
• Why do Risk Management attempts fail?
• Benefits of a Risk Management Program
• Introduction to A System Approach to Total Life Cycle Risk Management
• Effective Risk Management Process:
• Hazard Identification
• Risk Characterization
• Risk Estimation
• Risk Evaluation
• Risk Controls
• Critical Control Point Analysis
• Residual Risk
• Monitoring and Feedback
• Risk Assessment Tools:
• Process Mapping
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Fault Tree Analysis (FTA)
• Cause and Effect Analysis
• Failure Mode Effects Analysis (FMEA) etc.
• Risk Management Principles
• Risk Review
• Risk Acceptability
• Risk Communication
• Risk Control
• Effectiveness of Risk Control
• Integration of Risk Management with Quality Management
• Risk Management Plan (RMP)
• Corrective and Preventative Actions
• Composing scientific justifications
• Effectiveness evaluation
• Risk Management Audit