August 17th – 18th , 2009 | Toronto, Canada

A Two-Day Comprehensive & Interactive Course, With Workshops On:

An effective leader has the ability to get a group of diverse and talented people working together towards a common goal. Sounds easy in principle, and yet this can be a large challenge for many leaders today.

We have found that great leaders, many of whom have strong personalities, find ways to affect others in a positive way and have a lasting and determining influence on people's performances.

In order to succeed as a talented leader, you need everyone contributing and performing individual duties and responsibilities at a very high level of proficiency.

This one and half a day practical "hands on" Leadership Workshop provides tools and the "how-to's" to confidently lead others more effectively. The program focuses on key areas of leadership success.

The participants learn to:

• self-assessment
• Characteristics of today's workforce
• Skills required to be an effective leader
• Motivational strategies to address the generational mix
• Effectively communicate and influence others
• Manage fluent change
• Achieve the essentials for continuous growth
• Build trusting and positive relationships with others
• Influence growth and change in the organization
• Improve decision-making abilities
• Learn ways to effectively see the "big picture"
• Create and sustain great positive team dynamics through effective coaching and development techniques

August 10-11, 2009 | Toronto, Canada

A One & Half Day Comprehensive and Interactive Workshop On:

• Understanding GLP Regulatory Expectations for Documentation
• 21 CFR Part 11 requirements for GLP Documentation
• FDA Warning Letters
• Effective Documentation Practices
• GDP and Change Management
• Proper Maintenance of Documentary Systems
• Designing, Writing & Checking Protocols and Reports
• Effectively Preparing Standard Operating Procedures (SOPs)
• Policies, Records, Logs, Protocols, Forms, and Work Instruction
• Management of Raw Data
• Deviations versus Amendments
• Preclinical, Clinical and Validation Documentation
• Protocol Writing and Review
• Developing and Using Formats & Templates
• Effective Writing Skills
• Quality Manuals
• Reporting and Data Review for Deviations and OOS Results
• Auditing Sample Documents

August 20th - 21st, 2009 | Toronto, Canada

A Two-day Comprehensive and Interactive Course with Workshop on:

• Critical Elements of Stability Program and Stability Testing
• FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
• ICH Climate Zones
• Types of Stability Studies - Stability Study Designs
• Developmental Stability Studies (i.e., Phase 1 to 3)
• Consistency Studies for drug submission
• Validation Studies
• Routine Stability Studies (Marketed products)
• Setting-up Stability Program Policies, Procedures, SOPs and Study Protocols
• Preparation of Stability Reports
• Consideration in Developing Stability Indicating Methods
• Designing Reduced Testing Program: Bracketing & Matrixing
• Rational for Study Duration and Shelf-life Determination
• Testing Intervals; Long Term and accelerated
• Study Stability Batch Selection, Sample Size, and Sample Management
• Stability Chambers: Mapping, Qualification and Monitoring
• Study Tracking
• Stability Testing and Evaluation
• Stability Trending, Failure Investigation; OOS, and OOT
• Review of Recent Stability Related 483s

Sponsored by:

August 20th, 2009 | Montreal, Quebec, Canada

Featured Topics Include:

• Regulatory Expectations
• Non-Sterile Manufacturing
• Cleanroom classification schemes and Environment
• Setting up a meaningful Environmental Monitoring plan
• Microbial Identification
• Electronic Environmental Monitoring Program
• Interpretation of results
• Trend analysis and review of data
• Preparing EM Summary Reports

August 20th - 21st, 2009 | Somerset, NJ, USA

Highlights of Topics - IQ, OQ, PQ

• Introduction/Quality Systems
• Regulatory Requirements and FDA Directives
• ICH Q7,Q2(R1) and other Guidelines
• USP <1058> Qualification
• Measurement Resolution and Errors
• Calibration Standardization and Validation
• Calibration Master Doc
• Calibration Management
• Laboratory Systems
• Product Lifecycle Concept
• Responsibilities of Vendors and Users
  • IQ/OQ/PQ and PM
  • Validation and Qualification Strategies; Risk Assessment Approach
  • ICH Q9/ SO/ASTM guidance
  • Documentation Strategies; Master Validation Plan and Protocols
  • Development of Protocol (Case Study)
  • Examples of OQ and PQ
  • Examples of OQ, PQ: Some Select Protocols
  • HPLC Systems
  • Dissolution Apparatus
  • TOC, LC-MS and others
  • PQ vs. System Suitability
  • Training Requirements
  • Group Exercise