Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

In this webinar attendees will learn the guidelines on good storage & distribution practices of pharmaceutical products and the factors affecting the quality of products. Various types of storage conditions & environmental control processes will be discussed to avoid potency loss of drug products while stored in the premises.

This webinar will discuss the history of biosimilar - how EMA led the way and how FDA is catching up. It will give Insight into the varying regulatory approaches prevailing in different regions & overview of the Biosimilars picture across the world, the barriers (known as "The Patent Dance") to entry. It will discuss about interchangeability issues, what proof does FDA require, US biosimilar registrations success and failures and how to avoid failures. Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company.

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

This GMP audit webinar will discuss the importance of external GMP audit, FDA requirements, best practices and steps for external audit execution, reporting, follow up and quality agreements between company and its suppliers/contractors.

This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.

This webinar will be most beneficial to persons planning on writing and filing IND, NDA, ANDA, BLA applications to the US FDA; and to persons responsible for filing amendments to an existing paper IND. It will highlight summary of e-ctd requirements, format and content, how to prepare and file an IND application, how to do filing to an existing IND and best practices for IND submission.

This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

This supply chain risk management webinar will discuss the concepts and 7 principles of supply chain process, process mapping of your supply chain and how to develop a supply chain risk management plan starting from identifying each risk, evaluation, prioritization and risk management strategy for each types of risks.

This webinar will discuss the requirements, clauses and steps to comply with ISO 22716. It will help you understand how to maintain the quality of your products.

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

This webinar will cover the system suitability requirements and recommended adjustments to specific chromatographic systems in the USP monographs based on General Chapter <621> Chromatography. We will also discuss the most recent updates on proposed harmonization of this general chapter with EP and JP and how to implement the procedures after the change is effective.

This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.

This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.