Compliance Training Webinars for Regulated Industries

This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.

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

This Training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.

This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

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.

In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.

This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

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 explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

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

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.