Life Sciences
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FDA 483s, Warning Letters and Enforcement Trends
Publicly available warning letters and inspection observation data provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities within your quality system. The fiscal year 2019 saw the most warning letters issued by the FDA to makers of finished pharmaceutical products in recent history During the last 12 months, a total of 81 warning letter..
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 ..
Running a Virtual QMS
A paper based system is a physical record signed with a pen and maintained in a fireproof withing a quality facility. This type of QMS is burdensome and requires all employees to be located in the same location. What you need for a paper based system includes pens, paper, fireproof filing cabinets, office Space, office furniture, office security, computer/laptops, printer, file folders and Microsoft applica..
Assays Supporting Drug Development for Cell and Gene Therapy Products
Large molecule (biologic) drugs continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing, and post market monitoring. Included in this growth are cell therapy and gene therapy products. These new therapeutic approaches have the adv..
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures
21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures. The rule was, by FDA’s admission later, confusing and challenging. Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..
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 ..
When does a Medical Device Start up need a Quality Management System
As a startup developing a medical device, implementing a Quality Management System (QMS) is not just a good practice but a regulatory requirement in many jurisdictions. A QMS is crucial for ensuring that your medical device meets regulatory standards, operates safely, and delivers effective results to patients. Here's why and when you should start implementing and using a QMS:Regulatory Compliance: Regulato..
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..
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..
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..