Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

This webinar will describe the basic principles of drug metabolism, with specific emphasis on the various metabolic pathways and mechanisms that commonly reduce drug exposure. With greater understanding of these mechanisms, drug hunters have a higher probability of designing drug candidates that are less susceptible to metabolic clearance and elimination. The webinar will also highlight drug metabolism issues such as reactive metabolites and drug-drug interactions (DDIs) due to inhibition or activation of cytochrome P450 (CYP) enzymes. Common mitigation strategies for metabolism-related issues will also be reviewed.

Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and external spokespersons.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Technical Writing: A Detailed Process provides step-by-step instructions for experienced Technical Writers go from the blank screens to the final written presentations. The webinar includes procedures for the creation of document plans and meetings with stakeholders to produce the highest quality of Technical Documents. It provides guidance on the conversion of highly technical material into language easily understood by the general public.

In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.

In this training program, attendees will gain an understanding of general laboratory safety and common lab operation procedures. The course will also instruct on what PPE to provide such as safety goggles, aprons, gloves, eyewash stations, fire extinguishers, first aid kits, etc.

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of problems.

Attend this webinar to gain a clear understanding of understanding of what the Cannabis Act & Regulations state pertaining to the regulatory process and compliance responsibilities. You will take away a clear understanding of the licenses and permit requirements and the limits of the same, as well as methods of establishing best practices and SOPs.

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

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.