Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

In December of this year, USP 800 will take effect. Each entity that handles Hazardous Drugs (HD’s) must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures overseeing entity compliance with USP 800 and other applicable laws. This course will show you how to determine which of the almost 300 HD’s you need to handle in the same manner in the pharmacy and as they are excreted by the patient. We will look at recommendations from the international Society of oncology pharmacy practitioners (ISOPP) on the list of drugs with excretion times as well as other sources.

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 90-minute GxP Quality Management System webinar introduces you to the planning and implementation of a QMS using a pharmaceutical QMS as a working model and focuses on fundamental concepts of quality, managing quality, systems, processes, managing change and assessment tools.

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 will discuss current best practices in understanding, assessing and mitigating many preclinical safety concerns in drug discovery. It will highlight many of the primary factors impacting drug safety, such as drug properties, target and tissue specificity, metabolic profile and reactive metabolite formation. It will also demonstrate many modern preclinical mitigation strategies and techniques to improve the safety of potential drug candidates.