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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..
Pharmacovigilance Inspections
Regulatory inspections are the end result of the Company QMS assessment. Companies and Sponsors of trials need to have performed audits on all regulatory aspects to ensure compliance before the Regulatory Authorities assess with an inspection.This course will cover how the Regulatory Agencies interact with Companies, what they will look for and expect, the grades of findings, and what happens next after the..
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..
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handle by adjustments rather than the strict si..
Complaint Management for Medical Device Companies
In this webinar, we’ll start by reviewing the current state of complaint management (spoiler alert: it isn’t good!). We’ll talk about some of the common ways companies tackle complaints and why these methods are inadequate.We’ll then take a step back and review the requirements from regulations and standards. It’s important to understand what constitutes a complaint in the first place to ensure that t..
Risk Appraisals for Internal Audits in Pharmacovigilance
The audit program is an essential part of the QMS for the Company and prioritizing the scheduling and content of the audit is critical to the success of assessing the Company's compliance in preparation for a Regulatory Inspection.The course will look at the Regulatory Inspections of the audits and how the Company can justify the approaches taken in terms of Risk.The course will also detail those routine as..
Medical Devices – EU Medical Device Regulation 2017/745
This webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.Areas CoveredThis webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.Who Sho..
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..
Risk Management in a Medical Device Quality System
ISO 13485, the international standard for medical device quality systems, requires that all processes be done in a manner commensurate with risk. Sounds reasonable, but it must be thought out and planned. We frequently apply risk management and different levels of risk management without thinking. For example, most of us use a seat belt when driving. This could be considered the minimum level of risk ..
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..