FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

Attend this webinar to get an overview of the recent Brazilian changes regarding the big data protection in Regulatory Affairs. It is an opportunity to analyze and discuss key issues related to the data protection applicable to all medical, pharmaceutical, food and cosmetic product.

Attend this webinar to learn the logical, fast and simple process of how to easily write any document that your company requires. Explore how to organize collected information, write the document and address the comments from reviewers and approvers.

This Webinar is geared toward those who require a working knowledge of biocompatibility.

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 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.

This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.

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 webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.

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.

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.

The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients. The public information about the limits of toxic impurities and about nitrosamines in sartans will be discussed and possible similar situations reviewed in this webinar.

This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.

In this webinar attendees will learn the brazilian labeling requirement for food, cosmetic and probiotics products, Also attendees will gain a complete understanding of claims regulation for food, cosmetic and probiotics according with the local legislation.

This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.

In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

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 training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This FDA inspection webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.