This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
Not every parameter in the EO sterilization process in critical for the determination of the product’s sterility assurance level (SAL). This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions can be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the actions to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
This equipment cleaning validation webinar will explain cleaning validation program steps, cleaning agents selection, documentation, cleaning method set up and how to reproduce cleaning validation program and various simple but powerful tools for achieving an in-depth Cleaning Validation Program, and continuous monitoring that meets FDA expectations.
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.
This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.
This food safety webinar will discuss the currently accepted food safety practices and how the the newly evolving system for food safety is about to be put in place.
