FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.

A training package comprising three best-selling webinars that covers all aspects of the Physician Payment Sunshine Act, including the final rule, reporting and tracking requirements, how sponsors and investigators of clinical trials can comply and acceptable and unacceptable practices.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This webinar introduces the concept of Good Clinical Practice (GCP), primarily from a US perspective. The webinar presents an overview of the FDA’s GCP regulations for drugs and medical devices. It also summarizes the key objectives of GCP and the responsibilities of Sponsors of clinical trials and site level clinical investigators.

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.

Labeling to satisfy the requirements of federal government contracts has its own unique requirements. In this webinar, we break down both the requirements and what a typical process would look like.

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.

Responding to the public’s ongoing concern about high and rising drug prices, the Biden Administration and 117th Congress with a fragile Democratic majority have unveiled key proposals to lower prescription drug costs.

This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.

This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.

Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Implementing a Quality Management System (QMS) involves a structured process to ensure consistent quality across an organization's operations. It typically starts with understanding the organization's context, defining policies and objectives, mapping key processes, and then implementing, monitoring, and continuously improving the system. The implementation process can vary based on the organization's size and complexity, but generally takes 3-18 months depending on an organization’s size.

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.

The FDA sites hundreds of companies each year for not adequately performing and documenting out of specification results. This course is designed to provide instruction on how to thoroughly document and investigate out of specification results using approaches which have been recommended by regulatory authorities.

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.

Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.