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

This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.

This training program will examine the different types of social networks (Facebook, Twitter, etc.) and help identify similarities, differences, and challenges for pharmacovigilance (PV) professionals. It will also analyze social networks and the new approach to benefit/risk ratio.

This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.

This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.

This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.

This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.

This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.

This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's Design Control requirements.

This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.

This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.

This training program will assist 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. It will help attendees in determining how well your company is positioned to defend your FDA submission.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.