Compliance Training Webinars for Regulated Industries

This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.

This training program will provide an overview on how to create a business continuity audit plan that is effective and in line with the company's objectives. It will help attendees understand regulations, standards and requirements pertinent to business continuity audits as well. The webinar will define the risks or threats to the success of an audit plan and train attendees on how to test the controls in place to determine whether or not those risks are acceptable.

This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

This webinar will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

This Water system compliance training will give you a comprehensive knowledge about water system compliance with relation to Microbial Quality Problems, Microbial Testing, Endotoxin control, Sanitization, Water system validation.

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.

This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.

This JAPAN Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan with respect to regulatory filings and registrations.

This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters.

This webinar training will explain how to efficiently manage third-party and supply chain risk with the Common Controls Hub.

Third-party and supply chain compliance risk management is mandated for most organizations. However distributing, reporting, and tracking of adherence to control lists is so painful that many organizations do not perform due diligence at all or with the necessary frequency. Participants will learn how to self-assess their compliance and Internal controls.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

This HIPAA training program will highlight electronic record security regulations including requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.