Events tagged "Regulated Environment":

San Francisco CA, USA

In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA’s Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your company can ensure that they have a successful inspection. Read more »

Disney’s Contemporary Resort, Lake Buena Vista FL, United States

Chockfull of top-quality speakers, pertinent topics, crucial advice, case studies, expert panels, and practical take-away advice, this two day Medicare Marketing Summit will deliver everything you need to improve your marketing ROI in a Highly competitive and regulated environment. You will walk away with creative and practical solutions to all your marketing, sales, and enrollment needs. Read more »

Online Training

This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime. Read more »

Online Event

Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. This seminar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements. Read more »

Online Event

Why Should You Attend :

FDA expressly regulates databases and FDA inspectors are specifically trained to look for and at databases. Though database use is widespread throughout most organizations, most organizations lack a clear compliance strategy for ‘small’ databases. Many companies struggle with Access database compliance. Some are still using unvalidated databases. Hence an unplanned ‘emergency’ Access database validation project could paralyze the organization. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to Access. Read more »

Online Event
Palo Alto CA

This webinar will teach specific techniques to ensure your organizations are ready for regulatory inspections. We will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution. Read more »

Online Event
Palo Alto CA

This training class describes the mechanics of a sound maintenance program from a ‘Quality’ perspective, including the major issues that are typically emphasized during regulatory audits. You will learn how to develop thorough maintenance documents that are clear and confusion-free. Additionally, you will discover how to perform and document corrective work in a manner that eliminates ambiguity and misunderstanding. Read more »