Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss common problems of sanitization process, the causes of sanitization failures and teach how to troubleshoot and take remedial actions with respect to material, construction methods, biofilm removal process and timing of sanitization.

This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.

This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.

In this webinar attendees will learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

This analytical method validation webinar will help you understand the various parameters required for a successful method validation. It will highlight various requirements of USP and FDA for a successful method validation. This will be helpful for All pharmaceutical analytical chemists & supervisors responsible for validating new or modified analytical methods, and the personnel responsible for hosting FDA inspections, responding to 483s and Warning Letters or preparing NDAs or ANDAs.

In this webinar attendees will learn the good manufacturing practices required for any medical marijuana production operations related to international and US individual state cannabis regulations to determine how to best operate their cannabis operations.

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.