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Risk Appraisals for Internal Audits in Pharmacovigilance
The audit program is an essential part of the QMS for the Company and prioritizing the scheduling and content of the audit is critical to the success of assessing the Company's compliance in preparation for a Regulatory Inspection.The course will look at the Regulatory Inspections of the audits and how the Company can justify the approaches taken in terms of Risk.The course will also detail those routine as..
Medical Devices – EU Medical Device Regulation 2017/745
This webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.Areas CoveredThis webinar discusses key aspects of MDR: device classification, custom-made devices, technical documentation, clinical evaluation, post-market surveillance, economic operators, UDI and EUDAMED.Who Sho..
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?
This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows t..
Risk Management in a Medical Device Quality System
ISO 13485, the international standard for medical device quality systems, requires that all processes be done in a manner commensurate with risk. Sounds reasonable, but it must be thought out and planned. We frequently apply risk management and different levels of risk management without thinking. For example, most of us use a seat belt when driving. This could be considered the minimum level of risk ..
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..
Computer System Validation (CSV) 3-Hours Boot Camp
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 walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also ..
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..
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..
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..
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..