Compliance Training Webinars for Regulated Industries

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 webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks. The Instructor will explain how to measure an organisation’s susceptibility to a cyber attack and will outline critical action areas in such event.

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.

In this Risk Management webinar attendees will learn the resilience strategies, recovery objectives, cyber/information security, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.

This webinar is designed for managers and project leaders who have been tasked with implementing a computer security incident response team (CSIRT). Attendees will learn how to develop a CSIRT Policies, Program, Plan, Playbook, Training and Exercises in their organization.

This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.

In this presentation attendees will understand the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigation, notification, and disposition), examples of documentation you can use to fulfill the NCMR requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. It will also highlight additional tips and tricks on how to convey the importance of NCMR within your organization and ensure resources are provided to meet process needs.

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

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.

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.

If your company processes over $50,000 in credit card volume per month, this webinar will explain certain strategies that will help reduce the processing fees you are charged.

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.

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 90-minute training will provide you with an overview of a forced degradation study on a protein therapeutic and help you interpret and leverage the results to design stability studies required for registration of the BLA.

This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. We will discuss FDA 483s on the subject of Method Verification to understand current FDA expectations.

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 comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines.