Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

In this Pharmaceutical Quality Risk Management webinar attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, the level of risk based on severity, occurrence, detectability and how the QRM process is used to make decisions. Also attendees will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.

The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.

In this webinar attendees will learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.

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. The webinar presenter will use case studies to illustrate each stage in the process.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.

In this prescription drug pricing webinar attendees will the key components of the trump administration on drug pricing plan, elements of the white house drug pricing blueprint and the federal policy outlook for U.S. drug pricing in 2019 and beyond.

This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.

This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

This 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 focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.

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.

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.

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.