Compliance Training Webinars for Regulated Industries

This webinar will discuss the excel What-If Analysis tools within Microsoft Excel’s Data menu. In addition, it will explain Excel Scenario Manager, Data Table features, Excel’s Goal Seek feature, Excel Solver feature, FORECAST and more. Participants can avoid replicating worksheets. The advance functions can also help in comparing different scenario and extrapolate trends based on existing data in your spreadsheets.

This webinar will explore the common failures associated with organizing and writing Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) documents. It will also de-mystify some of the language and concepts in the traditional JHA process, namely the risk assessment calculator.

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results. It will explain HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov and provide the steps to registration process in clinicaltrials.gov site.

In this webinar participants will learn what Internal Audit can or cannot do and how the internal auditors can assist in ensuring that CECL processes are robust and complaint with regulator expectations. Attendees will also learn the best ways to leverage an internal audit department as the organization becomes CECL compliant.

This GMP audit webinar will discuss the importance of external GMP audit, FDA requirements, best practices and steps for external audit execution, reporting, follow up and quality agreements between company and its suppliers/contractors.

This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification.

The objective of this training is to better understand the breadth of retail payments compliance issues and how to create a framework for reviewing both internal and third-party responsibilities for a successful audit.

This webinar will explain how to calculate the correct valuation on a product while importing from related party suppliers. Instructor will discuss how to document transactions for CBP process and to recognize valuation issues that may cause price adjustments after import. Participants will learn to avoid adverse consequences of declared valuation errors and what are the downsides to participation in reconciliation.

This webinar on TUPE regulation will discuss the impact of various aspects of the regulations on your business and specifically on transfer of employees, limits of transfer, dismissing an employee, changing terms of employment, issues related to pensions, insolvency situations and overall how to manage the change.

This webinar will review current requirements of the Bank Secrecy Act, why to comply, how to comply, reporting techniques and current positions by the IRS and FinCEN.

This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.

This webinar will be most beneficial to persons planning on writing and filing IND, NDA, ANDA, BLA applications to the US FDA; and to persons responsible for filing amendments to an existing paper IND. It will highlight summary of e-ctd requirements, format and content, how to prepare and file an IND application, how to do filing to an existing IND and best practices for IND submission.

This CERT program based webinar will discuss how to categorize improper payment categories, how to document and respond in time for CERT medical record requests. How to implement proper audit and monitoring practices.

This webinar explores the issue of what should the process be between employer and employee when trying to accommodate individuals with disabilities while complying with the Americans with Disabilities Act.

This webinar covers the central role of CAPA for the FDA, challenges in building an effective CAPA system, gives a comprehensive understanding of a CAPA process which is highly effective and sustainable, becoming a tool for continuous improvement. It will discuss capturing and assessing potential CAPA’s, using risk-based assessment, documentation, determining true root cause, how to take preemptive preventive action and using metrics for long-term improvement. The course will also discuss potential changes as FDA considers integration with ISO 13485.

This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

This webinar will discuss the how to interpret cash conversion cycle formula which has direct impact on company’s liquidity, what and how to assess while acquiring inventory, collecting AR and paying AP efficiently. It will teach inventory accounting costing methods, how to finance inventory and control inventory costs.

This webinar will discuss in detail about the new FDA guidance on bioanalytical method validation, how it is similar and different from the earlier guidance issued by FDA and EMA separately. What are the new additional topics related to analysis of endogenous compounds and biomarkers, the details of method development and report writing and overall it will give a comprehensive understanding of the existing and new requirements.

This webinar will describe the elements and characteristics necessary for the development and writing of an occupational health and safety Plan. The main component of this Plan will be your ‘Company Safety Manual” however the actual Plan will encompass far more than a Manual.

This Trial Master File training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using check-lists and case studies to highlight common deficiencies and potential solutions.