Drug Development Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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 pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.

This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.

This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.

This webinar will focus on the USP and FDA requirements for qualification of the dissolution apparatus including guidelines for USP Performance Verification Test and FDA Advanced Mechanical Calibration. It will also provide an overview of USP General Chapters <1058> and <711>.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.

This webinar covers the excipients and APIs regulatory requirements, audit planning and execution, basic to advanced auditing techniques, with emphasis on advancing the auditor’s people-skills, effectiveness and reporting skills.

This training program will discuss in detail the method for predicting plasma drug levels from in vitro dissolution results. It will also provide details of the underlying scientific principles involved such as convolution, deconvolution and IVIVC with simple practical examples.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.

This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.

The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.

This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.

This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.