Live Webinars

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how […]

Objectionable microorganisms associated with a medical device or pharmaceutical product can cause a serious illness to a patient. By testing and identifying these mircoorganisms early in the manufacturing processes, controls can be put into place to prevent harm to the patients. Objectionable microorganisms are considered, if discovered, harmful to the patients. By identifying and controlling […]

This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report […]

Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency. This is integral to a strong quality system. If you want to improve SOPs writing and training materials that create more effective training as well as help in the reduction of […]

Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of validation planning, protocol writing, and change management. We’ll take a deep dive into all the steps […]

The MDSAP (Medical Device Single Audit Program) applies to all medical device manufacturers, wherein a recognized Auditing Organization can perform a single audit to ensure that regulatory authorities are satisfied with the results of the audit performed as per the guidelines of the regulatory authorities participating in the program. MDSAP allows a device manufacturer to be […]

This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. The Sunshine Act or Open Payments Program requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain […]

Method validation and method verification are related terms. Unfortunately, the terms are often incorrectly used interchangeably. They have immensely different analytical and statistical requirements; particularly for compliance with ISO/IEC 17025:2005. This results in confusion and the application of inappropriate or inadequate analytical evaluations. Microbiology laboratory accreditation will need you to understand the differences between and […]

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant. Human factors engineering is extremely integral to user/market adoption. Getting a product to market is difficult whether you are a struggling startup […]