Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.

This training program is tailored for practitioners treating pain. It will provide you with a better understanding of a DEA inspection and the records needed in the event of an inquiry by DEA or any state regulatory agency. Participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II through V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

This training program will discuss stem cell sources and how to control stem cell differentiation, technologies (FDA and non-FDA) that exist in stem cell technologies, and the future directions and opportunities that exist for stem cell technologies.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

This training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This comprehensive training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This comprehensive training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).