All FDA Regulated Industry
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..
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..
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
This session will include the requirements for all required cross-functional responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "no..
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data integrity, process and product quality, and consumer/patient safety.We will discuss traditional CSV vs. CSA, the draft guidance issued in September 2022 by FDA, indicating the differen..
GCP Risk Management and Risk-Based Monitoring
This webinar offers a comprehensive exploration of the critical elements involved in ensuring the ethical conduct, integrity, and success of clinical trials. Participants will delve into the foundational principles of Good Clinical Practice (GCP), gaining a deep understanding of its significance in maintaining the highest standards throughout the clinical trial lifecycle. The training will navigate the comp..
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..
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Conducting Effective GxP Investigations
By the end of this course, participants will be able to:Understand the different types of GxP non-conformances and their implications. Identify the key regulatory requirements for documenting non-conformances.Conduct effective investigations to determine root causes.Develop and implement corrective and preventive actions (CAPA).Use risk management principles to prioritize non-conformance investigations.Impr..
Is a Certificate of Analysis (CoA) Enough
The topic of the role of Certificates of Analysis (CoAs) in quality management and supplementary practices encompasses several key areas:Role of CoAs in Quality ManagementVerification of Product Quality: CoAs provide detailed information about the quality and purity of products, ensuring that they meet specified standardsTraceability: They include batch numbers and testing dates, which help in tracing any i..
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..
Product Disposition Process from a GxP Point
IP disposition and release are essential aspects of clinical trial conduct. These processes ensure compliance with Good Practice (GxP) guidelines and regulatory requirements, maintaining the integrity, safety, and quality of clinical trial data. The IP release process involves several crucial steps to ensure the investigational product (IP) meets all necessary quality, regulatory, and protocol-specific requ..
Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders And Systems
The plethora of data, both structured database records and unstructured data, such as documents, PDFs, Excel spreadsheets, and other key artifacts, makes the assembly of a clinical TMF/eTMF a daunting effort. There are many stakeholders sending in key data about the trial to the sponsor. The many artifacts come from a variety of systems based on differing technologies and platforms and using differing commu..
FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
The US FDA has determined that a predetermined change control plan or PCCP be included in the marketing submission for a medical device software that incorporates AI or machine learning models and algorithms. Manufacturers of AI or machine learning software devices are to anticipate or foresee potential modifications post FDA approval and these could be based on perceived risks foreseen or effectiveness imp..
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..
FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions
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 syst..
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 “V” Model And System Development Life Cycle (SDLC)
Most of the concerns of industry can be managed through contracts and Service Level Agreements (SLAs) that benefit both provider and client. It all depends on how much a company is willing to trust a vendor and how much money they’re willing and able to pay for the service. A key to success is having a tight contract where the client can include the leverage with which they want to hold the cloud service pr..