Life Sciences
Refine Search
Selecting a CRO to Support GxP Analytical and Bioanalytical
This Webinar suggests objective components in the selection of CRO.Components include inspection and rebuttal of warning letters and 483 issued by the FDA or other regulatory entity, and answers/defense of the same by the CRO. Areas Covered Philosophy of the CRO to meet regulatory requirements, interpretation of suitability exercises. Philosophy of training skills and skill..
Dealing with Bad Data: Errors and Outliers in GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.In the case of an apparently anomalous data point, assessment of whether it really is an outlier using statistics is done. If so, an asse..
Designing Medication Adherence within a Patient Support Design Framework
Real-world outcomes have become an increasingly important metric for measuring value. Part of this value centers on the increasing emphasis on the patient (consumer) experience. To this end the industry needs to not only consider the standard “care” or utilization data that is currently available, but also (and perhaps more importantly) more deeply consider what data could or should be gathered if we are to..
Computer System Validation (CSV) Boot Camp
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct 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 discuss 2..
Critical Risk Assessment for Software Validation
Revolutionizing CSV Embracing Critical Thinking, Risk Analysi,s and Cutting Edge Tools in an Evolving Tech LandscapeDemonstration of Risk Assessments ConceptsDemonstration of Risk Assessments Tools and StrategiesPivoting Away from Traditional Risk Assessments and Encompassing Critical ThinkingPivoting from CSV to CSA with Critical Thinking/Risk Assessment in MindReal World Highlights of CSA Implementation C..
Real Life Case Studies in AI/ML
Real Life Case Studies featuring ML/AI, including Predictive Maintenance, Defect Detection, Environmental Monitoring, CAPAs, etc.Demonstration of Foundation of AI/MLDemonstration of Real Case Studies in Industry (non-Life Science)Demonstration of AI Validation Workflows and ProcessReal Life Case Studies featuring ML/AI in Life Sciences, including:- Predictive Maintenance, - Defect Detection,- Environmental ..
Data Process Mapping
Using Process Mapping in Data Integrity Governance.Demonstration of key issues 483s and Warning Letter Trend in Data IntegrityDemonstration of Data Process Mapping Assessments ConceptsDemonstration of Data Process Mapping Tools and StrategiesUtilization / Latest Industry Trends in Data Process Mapping with Data Integrity GovernanceIntegration of data process mapping is a vital component of effective data go..
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..
Best Practices for a Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that y..
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..
CAPA Best Practices and Pitfalls to Avoid
For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s). And there’s no sign that things are getting any better.CAPA and CAPA-related findings include lack of documentation / documented evidence, lack of timeliness, root cause(s) not being identified, failure to show effectiveness of actions, and on and on. Bas..
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations
In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a raw material or packaging component used in conjunction with the product during the manuf..