Compliance Training Webinars for Regulated Industries

The core of the presentation will be an in-depth look at Section 404 and the COSO Guidance used by most organizations for compliance. We will describe the SOX legislation including the creation of the Public Corporation Accounting Oversight Board (PCAOB) and key sections of the Act.

In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?

The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

Effective internal controls keep track of inventory and ensure that its proper value is reflected on the financial statements This presentation will provide you with the tools you need to establish and maintain strong internal controls for Inventory that meet Sarbanes-Oxley standards

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.

This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.

This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.

This presentation will give organization information as to how to organize itself and create a Lean Project Plan to roll-out the various lean techniques. This Webinar will provide valuable assistance to all companies looking to identify and remove waste in processes and value streams.

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134). For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing and laboratory processes in the medical device, pharmaceutical, and HCT/P industries.

An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.

This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.

This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.

In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not