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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..
Alternative New and Innovative Pretreatment Technology for Pharmaceutical Water Systems
Pretreatment technology is the first step in pharmaceutical water purification. Pretreatment modules are the preparation of water to be delivered to purification modules of Reverse osmosis, ion exchange, distillation, and micro and ultrafiltration. Poor pretreatment engineering will have a negative impact on the performance of the downstream purification module, causing undue maintenance, costs, and lack of..
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data integrity, process and product quality, and consumer/patient safety.We will discuss traditional CSV vs. CSA, the draft guidance issued in September 2022 by FDA, indicating the differen..
An Overview of Ozone, Chemical, and Hot Water Sanitation Methods for Pharmaceutical Compendial Waters
Sanitization is imperative to maintain a very pristine water supply for production purposes. Sanitization is not an absolute value but a reduction in viable bacteria. Sanitization is determined by the logarithmic reduction of the microbials. 103 is considered “sanitization”. 103 - 105 log reduction is designated as “disinfection”.A 106 log reduction is considered “sterilization. It is imperative to di..
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..
Generics - Are Big Pharma and The Generics Industry Enemies or Friends?
A large number of patent battles have been fought between generic companies and originators. Many patent lawyers have retired, having become rich on the fees that they have charged to conduct these court battles - and that can be true whichever side they are working with!However, this webinar is not about the lawyers, but rather about the companies that they represent in court. There have ..
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..
What is IMDRF and What is The Value to Industry to Engage
This event will help you to learnabout IMDRF. The event will allow you to understand the history and the associated stakeholders, including the countries that are actively engaged in the development. You will also learn about where harmonization has been achieved as well as where there continues to be challenges like in device classification, risk and practice of medicine. The event will help OEMs understan..
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..
Pharma and Biopharma Application, Market, and Segment Assessments for Ultrafiltration (UF)
Ultrafiltration (UF) is the highest barrier to contamination of the water after generation. UF low molecular weight rejection at 5,000 – 6,000 daltons and small pore size offers the best mechanical barrier to endotoxin carry over. This presentation describes all the filtration issues from larger micron sized used in microfilters to the ultralow nanometer sized filtration. Filtration in the pharmaceuti..
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..
Biosimilars - are they right for you?
The first biosimilar (Omnitrope = somatropin) was registered by the EMA (European Medicines Agency) in 2006. By contrast, the FDA was not able to register any US biosimilars until 2015, when Zarxio (filgrastim-sndz) became the first biosimilar product to receive US approval.Since then, the FDA has been playing “catch-up” so that by mid-2024, the number of US-approved biosimilars was 60 compared to 106..