Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

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>.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

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 will help attendees understand FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Attendees will understand different types of cosmetic testing, when they are applicable and related compliance requirements.

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 on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.

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 explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.

This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water systems, their validation, and handling of excursions.

This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.

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 cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.

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 webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.

This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.

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.