FDA Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.

In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations. This one-hour online seminar is designed to discuss the principles applied to the operation and cleaning of cleanrooms to ensure the contamination control.

This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.

This FDA compliance webinar provides FDA’s current thinking on modernizing the regulation of quality and manufacturing science through establishment of a new regulatory framework.

This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century

This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay

This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.

This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.

This webinar will highlight and summarize the 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.

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.

This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.

Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

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

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.