Biotechnology Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.

This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.

This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.