OVERVIEW Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturi...

OVERVIEW You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV). This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System...

OVERVIEW This Computer System Validation Training will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsou...

With the finalization of the FDA’s FSMA Preventive Control Rules, new FDA outbreak testing technologies and increasingly complex supply chain controls, spices and other low moisture foods are becoming increasing identified as outbreak contributors. Spices are frequently found to carry salmonella, are full of physical adulterants, are often not identified as allergens, and may be impacted by lead and, when not carefully controlled through...

In this webinar, I will discuss the importance of being ready for a Notice of Inspection (NOI) - also referred to as audit by Immigration and Customs Enforcement (ICE), what happens when an ICE audit occurs, and an employer’s potential liability for I-9 errors discovered by ICE in the audit. The webinar will discuss the need for preventive maintenance – an employer performing an internal I-9 audit - which should discover many of th...

This complaint management webinar will include the requirements for defining, documenting, and implementing a customer complaint handling system, including the customer complaints procedure for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This webinar will discuss the best way to document customer feedback management, what constitutes a customer service complaint, and what do with "non-compl...