Life Sciences
Refine Search
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and e..
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)
Good documentation Practices (GDP) are an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general r..
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..
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 for 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 their practices and products is through data and documentation, mea..
Computer System Validation (CSV) Boot Camp (3-day intensive training)
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 dis..
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..
Cleanroom Microbiology and Sterility Assurance
This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The typ..
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..
Corrective and Preventive Action (CAPA) and Root Cause Analysis
Recognize that CAPA is arguably the most important process in the quality management system because so much else depends on it. CAPA is used to handle not only poor quality (the traditional application) but also audit findings, customer complaints, and outputs of the management review. It can even be deployed against the other six Toyota production system wastes by treating them as "nonconformances" or, mor..