February 25-26, 2010 | Montreal, Canada

A one and a half day course covering GMP essentials including:

• History of US GMPs
• International Regulatory Authorities and Regulations
• Regulations and Guidelines
• Personnel and Organization
• Buildings, Facilities, and Utilities
• Equipment
• Materials Management and Supplier Controls
• Manufacturing and Packaging
• Labels and Labeling
• Laboratories and Testing
• Storage and Distribution
• Records and Documentation
• Risk Management
• Validation
• Quality Management Systems
• Change Management
• US FDA Inspectional Process

Interactive Group Exercise:

• Mapping your process to GMPs to ensure compliance

February 24-25, 2010 | Montreal, Canada

An Interactive and Comprehensive One & Half-Day Course On:

• Formulation and Production cGMPs
• Pharmaceutical Mixing
• Materials for Direct Compression
• Formulation with Binders, Fillers, Glidants, Lubricants, and Disintegrants
• Screening and Sieving - Particle size reduction
• Dry Granulation and Wet Granulation
• Fluid bed Technology
• Tabletting Principles and Equipment
• The Seven Stages of Compression
• Maximum allowable Punch Tip Loading Overload systems.
• Tablet Tooling –Elegant products are dependant on tooling design.
• Challenges with concavity and engraving
• Coating Principles and Equipment
• Sugar Coating, Film Coating, Modified release Coating
• Understanding colours, polymers and spray application
• Encapsulation Principles and Equipment
• Scale-Up and Technology Transfer Considerations
• Problem solving and Troubleshooting
• Future Trends and New Technology

March 2-3, 2010 - Montreal, Canada

About the Workshop:

The essentials for conducting an investigation of an out-of specification result in a compliant, reliable, and timely manner include having a well-organized and understood process; having well-informed and well-trained analysts, supervisors, and manufacturing personnel; and maintaining clear and concise documentation. The firm’s procedure for investigating out-of specification results should describe the various phases of the investigation and the recommended timing for the completion of the phases. The types of errors that may arise and how to deal with them should be defined. Checklists may help determine the presence or absence of certain types of errors. The procedure also should provide for the thorough documentation of the investigation.

The best practice is to minimize the generation of out-of specification results. Careful description of methods and reportable values, including appropriate system suitability parameters, can help to avoid out-of-specification results. Qualification of equipment and analysts and rigorous transfer of analytical technology will help to ensure that a laboratory is fully capable of performing an analytical method.

This two-day presentation will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. It will also offer guidance on how to establish or reestablish limits that are appropriate to the specific manufacturing process. There will also be discussion on how to document the results of the investigation.

Pharmaceutical and Biopharmaceutical Stability:
Current Trends and Best Practices to Support Global Markets

March 23-24, 2010 - Jersey City, 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

February 21-23, 2010 | Dubai, United Arab Emirates

Dear friends & Colleagues,

The International Pharmaceutical Academy (IPA) would like to extend an invitation to pharmaceutical and biotechnology scientists and technologists from throughout the world to join us at Dubai’s upcoming fourth “GMP-Update 2010” conference and exhibition that will be held from February 21-23, 2010 at the Grand Hyatt Hotel in Dubai, United Arab Emirates under the auspices of the Julphar Pharmaceutical.

For the last four years Dubai’s GMP-Update Forum has been the preeminent conference for pharmaceutical, biotech and device compliance professionals focusing on the full spectrum of topics which are of universal interest and addresses the implications of what the current key GMP requirements are, and how are they changing, or interpreted by various regulatory agencies.

February 2010 is fast approaching and we invite all professionals of the global pharmaceutical and biotech communities, and regulatory agencies to mark these dates and make every effort to join us in Dubai, one of the world's most sought after meeting and tourist destinations.

The quality and diversity of this year’s event is mainly due to coalition of senior technical and compliance experts from pharmaceutical, and life sciences sectors addressing several hot topics that are particularly important to your day-to-day professional function including:

• Quality Control for biologics
• Planning and conducting Viral Clearance studies
• Regulatory aspects in biotechnological manufacturing
• Development and manufacturing of biopharmaceuticals
• Filtration and Separation technologies
• Computer & Software Validation
• Design and Management of  Environmental Monitoring Program Design

We anticipate that 150 - 250 delegates will attend this 2010 conference. This conference will provide attendees with a tremendous opportunity to network with fellow colleagues, industry experts, and key vendors of equipment and supplies. Lunches and refreshment breaks will provide a relaxed opportunity to discuss the issues raised during the day’s presentations and allow time for visiting with vendors.

See you February 21-23, 2010 in Dubai for this unique and interactive learning opportunity!

Yours sincerely

Dr. M. Barghian