Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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.

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.

Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.

This SQM webinar will discuss how to establish a Supplier Quality Management program from selection to approval, the ON-going maintenance and disqualification of suppliers will be explored through definition of supplier classifications. How to build risk management into the process will be discussed. The webinar will explore the use of Quality Agreements to manage suppliers.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.

This Drug GMP webinar will review the pharmaceutical GMP regulations and discuss how to avoid deviation from them, what to do when deviations do occur and what happens when the regulations are not followed. It is crucial that all employees involved in pharmaceutical quality be familiar with these regulations and review them on a regular basis.

In this 1-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.

This webinar will evaluate guidelines for recreational drug use during breastfeeding, how to counsel mothers who are breastfeeding and using recreational drugs, including marijuana and also Evaluate ethical concerns regarding marijuana use.

This Biologic stability webinar will discuss the issues present during design and implementation of stability program for large molecule therapeutics. We will discuss the design and validation of stability indicating methods and expiry dating.