Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.

This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

Regulatory expectations for reporting in multi-company development and marketing programs.

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6. This program is essential for management of clinical trial sponsors and vendors.

This webinar will cover the concepts of critical cleaning, FDA requirements and cleaning validation. This webinar will enable one to approach issues surrounding cleaning validation.

This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies. This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry.

This webinar will provide valuable background for those who need to evaluate viral clearance data.

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.

This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.

This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.