Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to made and periodically as necessary.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

Structure Alerts, also known as toxicophores, are classes of chemicals, functional groups or substructures that, when present in drugs or drug candidates, have been linked to preclinical toxicity and/or adverse drug reactions in humans. This webinar will define and describe many of those structure alerts and outline the mechanisms that have been associated with their toxicity. Mitigation strategies will also be discussed.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.

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.