Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 dietary supplements will cover product ingredient reviews and FDA requirements for labeling your products in the US. You will learn how to avoid claims, what claims are permissible and how to remedy challenged claims.

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 session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This training will cover FDA requirements for labeling dietary supplements. It will show how you can avoid dietary supplement labeling claims by properly labeling your products for the US market per FDA requirements.

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

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 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 DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.

This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.

This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

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.

This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.