This webinar will discuss in detail the use of the Global Harmonization Task Forces (GHTF) and Notified Body Operations Group (NBOG) supplier guidance documents to create QA agreements. Attendees will learn best practices to ensure compliance with FDA and EU guidelines for supplier quality agreements.
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
In this webinar, learn how to develop a data integrity governance program, and the principles for defining quality and data integrity processes and systems. It will examine common issues from FDA 483 observations and explain how to prevent them.
In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
Labeling, Advertising and Promotion of drugs, biologics and medical devices are heavily regulated and aggressively reviewed on behalf of the regulators such as FDA, FTC and other Federal Authorities. This course provides an overview of label development, building a Target Product Profile, the label’s impact on advertising and promotion, and recent changes in how these areas are monitored and enforced.
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process outputs and quality results.
This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.
This session will discuss the issues surrounding the use of various communication technologies under HIPAA controls, and the recent guidance and declarations from HHS about HIPAA and the response to COVID-19
This training will prepare hearing officer for corrective actions and how to prepare for the hearing. It will cover application process for new applicants which include prior practice, references, prior adverse actions and liability settlements. Attendees will learn elements of good, clear and concise bylaws, fair hearing plans and other policies.
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
This healthcare coding webinar will provide an overview of ICD-10-CM, the format and guidelines. It will also explain the differences between ICD-9 and ICD-10 to help you understand how it will affect your work and as well as your co-workers and providers.
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.
Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.
This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
