Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will help you understand the industry background to the current transition to Risk-based Verification processes and the current trend in implementation by industry. You will learn the regulatory foundations, industry guidance, and primary components of risk-based verification as it relates to an overall specification, design, and verification program as outlined in ASTM E-2500-07; “Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment;” ASTM, 2007. Key implementation considerations and initial steps will be discussed.

This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.

This webinar on sterilizing grade filter validation will describe the essential requirements and steps for process validation of sterilizing grade filters. It will discuss multiple guidance documents in regard to sterilizing grade filtration and their interpretation.

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

This 90-minute webinar will provide a clear understanding of the concepts of computerized system validation, and describe the steps to be taken by a project team for a well-controlled and successful computerized system validation.

This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

This EU MDD webinar will help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.

This 6-hr training provides a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information includes preparation of protocols and reports, application of Statistical Process Control, concepts of Design of Experiments, using attribute sampling plans, and a discussion of GHTF document on process validation.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.

This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.

This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.

This webinar will provide participants a good understanding of FDA requirements for training and provide recommendations for implementation.

This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

This 90-minute webinar will help you understand the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.

This 90-minute session will cover the basics of freeze drying as it relates to the pharmaceutical, biological and food industries. Specifically, this session will highlight using a scientific approach to developing an optimal formulation and lyophilization cycle for those freeze-drying in these industries.

This Water system validation training will guide you on how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system.

This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.