Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage and usually factors associated to cognitive load are ignored. In science, cognition is the mental processing that includes the attention of working memory, comprehending and producing language, calculating, reasoning, problem solving, and decision making. This course evaluates cognitive issues that may be the cause of these failures.

Attend this webinar to understand the definitions of in-house IVDs, the regulatory requirements including classification & essential principles, the NATA requirements related to how and when IVDs can be used as a research or diagnostic tool and the current laboratory supervision requirements for the ability to perform and report on in house IVDs.

Attend this webinar to learn how to create a GMP compliant training program and avoid human errors when implementing/improving a training program. It will discuss important elements like curricula, training management systems, training effectiveness and more.

In this webinar, get an overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. It will cover pertaining regulations and their applications to provide success when being reviewed by an auditor.

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.

This training session is intended for 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. The program will provide effective and practical solutions to address real-world issues.

This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.

This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its shelf-life.

This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy to read and clear SOPs your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow your manufacturing processes.

Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.

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 program is intended for 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. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

In this webinar attendees will learn the background of all sections of ICH Q7 guidance, key critical section contents, the authors intent when writing critical parts of this guidance and how to apply Q7 in an Active Pharmaceutical Ingredient (API) facility.

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.

This program will provide foundational knowledge of orphan drug development, including the history, leading to today’s standards and requirements. You will get an overview of current regulatory and legal requirements. This basis will serve to advance understanding of your role in the drug development process.

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.

The GxP internal audit (IA) is a potent routine, systematic, independent process and product assessment, assurance and improvement tool. The audit report, the auditor’s analysis and interpretation of the engagement, is the primary record and must communicate audit analysis results to stakeholders and engage responsible parties to act. Without an effective audit report the audit itself is meaningless. The focus of this 90 min webinar will be the structure, content and style of the audit report as well as tools to help to maximize its impact and utility.

This webinar will discuss key components of requirements and expectations for sponsors conducting nonclinical safety studies at Contract Research Organizations (CRO’s). The webinar will also review Sponsor responsibilities for assessing and auditing CRO’s conducting nonclinical studies on their behalf.

This webinar will discuss current best practices to predict potential safety risks in drug discovery. It will describe how early target assessment and analysis can help identify potential safety risks, allowing researchers to design issue-specific mitigation approaches. It will also describe how predictive toxicology and in silico methods can work together and inform drug discovery optimization campaigns.