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.
In this webinar attendees will learn the brazilian labeling requirement for food, cosmetic and probiotics products, Also attendees will gain a complete understanding of claims regulation for food, cosmetic and probiotics according with the local legislation.
In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
This HIPAA Privacy Workforce Training will cover all ongoing activities of a Privacy Program, Notice of Privacy Practices, and workforce expectations. Also this training will provide an overview of HIPAA authorizations, consents, patient’s rights, breach notification, key privacy definitions, penalties for non-compliance and best practices for securing Protected Health Information (PHI). In addition, training will provide an overview of personal representatives and uses and disclosures required by law and safeguarding PHI.
This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.
This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.
In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.
This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-engineer a case management department and tips for identifying the best model for your organization.
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
This healthcare documentation webinar will discuss how to create a lawsuit-proof, auditable nursing documentation and how to maintain compliance over the course of the document life-time. You will learn how to de-risk your documentation so as to withstand legal scrutiny.
This webinar will explain how to select an effective Chief Compliance Officer (CCO) or Chief Risk Officer (CRO) best suited to the position. It will also review the skills needed to communicate the essence and structure behind a good compliance program.
This CMS QAPI standards webinar is designed to help surveyors assess compliance with the hospital CoPs for QAPI(Quality Assessment and Performance Improvement). This worksheet is used by State and Federal surveyors on all survey activity in hospitals when assessing compliance with the QAPI standards including validation and certification surveys.
This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.
This Healthcare webinar will explore the complications and requirements of each of the rules controlling student health information, HIPAA, FERPA, and 42 CFR Part 2, and provide insights into how to apply the rules in an education setting.
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
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.
