Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.

This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.

This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence

This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.

This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process

This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.

This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA. The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.

This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

This Pharmaceutical training starts with the drivers for outsourcing and investigates the importance of measures of success and how they apply in implementing strategy.

This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations

This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

This Product safety training examines how product safety can fit into a stage gate new product development process, and provides recommendations and examples on how to make product safety become an integral part of the new product development process

This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.

This FDA compliance training offers pragmatic approach to dealing with FDA mandated quality systems. The approach offered emphasizes function over form. Anyone subject to 21 CFR Parts 210, 211 and 820 will benefit from this seminar.

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.

In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.