Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 onboarding course is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively, and suggest similar actions that learners can apply to their job situations quickly.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

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.

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.

In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

In this Pharmaceutical Quality Risk Management webinar attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, the level of risk based on severity, occurrence, detectability and how the QRM process is used to make decisions. Also attendees will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.