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Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices while b..
GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)
Gain an understanding of how newer technology should be handled when performing validation work. A different approach will be covered during the session.We will also discuss best industry practices to ensure all systems, including technology that has been around for decades, yet until recently, these were rarely used in the life science industry. (e.g., cloud, Software-as-a-Service (SaaS), Electronic Record..
Effectively Managing CMO / CDMO
Regulatory expectations are clear about manufacturers’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufacturers are responsible for ensuring their suppliers adhere to quality standards, maintain compliance to regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medi..
Software development for Medical Devices under IEC 62304
IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..
The Identification and Auantitation of Low-Level Compounds for Impurity and Degradation Analyses
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types substituent positional, optical, and alkyl are some – becomes critical since these may differ in toxic effects. The need for definitive qualitative..
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 handled by adjustments rather than ..
Standards – Fact, Fiction or Fad?
This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards ..
Writing and Enforcing SOPs: Best Practices for Regulated Industries
Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. Participants will learn how to organize and delive..
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance
Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or rep..
Performing Virtual Internal Audits
Conducting a virtual internal audit has become increasingly common in today's digital age, especially with the widespread adoption of remote work and technological advancements. While traditional audits involve physical presence and face-to-face interactions, virtual audits leverage digital tools and platforms to achieve similar objectives efficiently. Whether due to pandemic-related restrictions or the nee..
How to Conduct a Human Factors / Usability Validation
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 10..
The Transfer Of Validated Methods
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage and handling procedures, and other variables are common and can lead to different results. Making each operation..
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability and Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU). We will compare and contrast these with the CPRA, providing specific requirements and how..
Understanding The Food Safety Modernization Act: What Food Importers Must Know
The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. Third Party Certification: The FSMA..
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..