All FDA Regulated Industry
Human error reduction in GMP manufacturing/floor
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall h..
Preventing Human Error in the Life Sciences Mitigate Your Potential for Error Occurring
This webinar will describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings. The impact of human error in manufacturing will be examined as a prelude to the discussion of human error i..
Post Market Surveillance and Project Management Ensuring Long Term Success
This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success. The session kicks off by exploring the nuances of post-market surveillance, elucidating its definition, scope, and pivotal components such as continuous monitoring, customer feedback mechanisms,..
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend its practices and products is through data and documentation, meaning both struc..
Behaviors Leading to FDA inspection Disruption. Avoid It
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) was signed into law. Section 707 of FDASIA added section 501(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, war..
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?
This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows t..
Computer System Validation (CSV) 3-Hours Boot Camp
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also ..
Writing Investigations that Meet Regulatory Requirements
In this immersive 90-minute seminar, participants will embark on a comprehensive exploration of the critical landscape surrounding the creation of investigations that meet stringent regulatory requirements within the life sciences. The journey begins with a foundational understanding of the regulatory environment, delving into the vital role that compliance plays in shaping the integrity of scient..
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)
In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.We will discuss traditional CSV vs. CSA, the draft guidance issued in September 2022 by FDA, indicating the differen..
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..
5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..
Analytical Method Validation and Transfer
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of thi..
Basic Validation Statistics for Non - Statisticians
In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the c..
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures
21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures. The rule was, by FDA’s admission later, confusing and challenging. Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..