Compressed Gases -Vendor Audits, Safety and Testing in GMP environment

Live Web Training Course
Wednesday, August 11, 2010

Gasses are employed as “invisible helpers” in most areas of industry. Such areas include many processes in the manufacture of (APIs) and pharmaceuticals. This session will cover the points to consider when using compressed gases and qualifying vendors such as manufacturing, distribution, storage and equipment used . How to establish product specifications and documentation requirements from vendor for compressed gases at your facility which includes analysis, tankers, and documentation. This will provide pointers for auditing compressed gas vendors and ensure consistent quality of supply.

Understanding Health Canada's cGMP Guidelines for Natural Health Products

Live Web Training Course
Tuesday, July 13, 2010

Introduction:

The first session will review Division 2, Part C (Good Manufacturing Practices) of the Canadian Food and Drug Regulations, and include a brief overview of the historical context.

The second session will cover the modifications to the Canadian Good Manufacturing Practices (GMP) Guidelines, and concentrate exclusively on the 2009 changes including the new Requirement for Annual Product Quality Reviews..

China's Regulatory Agencies & Regulatory Compliance Requirements - Parts I & II

2-Session Live Web Training:
Session 1: Tuesday, August 17, 2010
Session 2: Tuesday, August 24, 2010

This course will specifically focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China, and will cover topics relating to pre-clinical and clinical requirements, as well as addressing the structure of their regulatory agencies. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations, and what is expected in the authorization and dossier maintenance of licensed products.

Instructor:

Robert J. Russell

Change Control Management for a Stability Program

Live Web Training Course
Tuesday, August 10, 2010

The stability program is vital to the manufacturing of pharmaceutical products, with inevitable changes throughout the product life cycle.  Examples of these changes include formulation improvement, new findings such as impurities, varying market requirements, additional packages and different formulation.  These changes will influence the stability profile  of the finished product, significantly impacting the drug development, regulatory submissions and commercialization.

Instructor: Kim Huynh-Ba

Analytical CMC Studies for Biotechnology Products: ICH CTD Requirements

Live Web Training Course
Friday, August 13, 2010

The development and commercialization of biotechnology products involves several specific analytical studies to be performed with suitable experimental designs and at the appropriate time in the product’s lifecycle.  The type and nature of each study is given in various FDA, EMEA and ICH guidance documents.  However, it is not often clear how these studies fit together to complement one another, or what key technical information should be provided in the regulatory dossier during development and at time of market application...

Instructor: Nadine M. Ritter

Stability Studies for Biologics and Therapeutics

Live Web Training Course
Wednesday, August 18, 2010

Introduction

The conduct of Stability Studies on Biologic products present several unique challenges due to their complexity and fragility. This live and interactive web training course will provide an overview of the regulatory requirements for conducting stability studies of Biologic Drug Substances and Therapeutic Products.

Instructor: Dr. Nanda Subbarao

A Review of Sterilization Methods for the Medical Device and Pharmaceutical Industries

Live Web Training Course
Monday, July 12, 2010

Many individual sterilization methods for the Medical Device and Pharmaceutical/Biotechnology Barry A. Friedman Industries exist for use in today's environment.  In addition, with the increasing number of combination products, it is not unusual to find that several sterilization methods must be used sequentially to obtain an acceptable product or kit available to the patient.

Historically, steam, dry heat, and chemical sterilants were the prominent modes of sterilization.  While steam and dry heat were successful, chemical sterilants have proven to be less reliable.  More recent innovations include ethylene oxide, gamma irradiation, filtration and electron beam, and each of these has found a place in today's terminal sterilization market.

Instructor:

Barry A. Friedman, PhD