This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.
This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enforcement action.
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.
HIPAA Privacy Officer Training will provide a comprehensive overview of all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization’s policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization’s information privacy practices.
This training program will cover in detail the CMS regulations and interpretive guidelines for medical records. It will also discuss important proposed changes to the CMS discharge planning standards including changes to the federal law on alcohol and drug records.
In this webinar, learn how to establish internal processes to ensure that compliance of materials is appropriately assessed, evaluated, and documented. Gain a full understanding of potential risks associated with materials and develop the ability to mitigate risk through subtle but important modifications.
This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.
This webinar will cover the legal regulations for dispensing and record keeping of controlled substances. This training will discuss the new changes in food animal antimicrobial drugs from OTC to Rx. Compounding guidelines and legal ramifications of dispensing human drugs to animals will be discussed in detail. It will review new drug dosages forms and extra labels use and further it will review what is legal for technicians and what to do when handling medications.
This ‘Wearable Devices in Clinical Trials Webinar’ will provide insights into how wearable devices work, how to find quality devices, how to derive the optimum value from the collected information, and how to position your business for the growth in this field. It will also review the new mobile devices guidelines of the Clinical Trials Transformation Initiative (CTTI, a private/public partnership initiated by Duke University and the FDA).
This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
You may find out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. Don’t let that happen. This webinar will teach you how to submit compliant and adequate software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. Also, learn how to avoid the potential audit risk which might prevent you from selling the approved product if you have been found to not have an IEC62304 Compliant Software Quality System.
This Medical Device Security webinar will focus on industry leading practices to assist healthcare delivery organizations (HDOs) with the integration of security into medical device procurement to inform procurement decisions, contractual requirements, and compensating controls. Also attendees will learn the required steps involved in the procurement process, some of which include vendor-level and product-level assessments, contractual requirements, and publicly available resources to assist with standardization.
This webinar will discuss the new elemental impurities test requirements as per the new ICH Q3D and USP 232/233 Guidelines, the testing required to comply with it and how to do proper risk assessment and analytical measurements, which drug products are within the scope, the documentation related to control of elemental impurity, which methods required to be validated.
