Compliance Training Webinars for Regulated Industries

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 webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

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 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

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 webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

To be certified with FSSC 22000; a food manufacturing needs to implement processes that address all the Requirements of FSSC 22000. This Webinar lumps together the Processes including Resources and Trainings needed to implement FSSC 22000.

The Medical Device Classification webinar explains the classification system in US and the EU.

This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.