Live Webinars
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4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach, as well as how to incorporate it into the overall computer system validation program for individual […] -
Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance
This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a […] -
Is it Microbiological Method Verification or Validation, or Just Semantics?
Method validation and method verification are related terms. Unfortunately, the terms are often incorrectly used interchangeably. They have immensely different analytical and statistical requirements; particularly for compliance with ISO/IEC 17025:2005. This results in confusion and the application of inappropriate or inadequate analytical evaluations. Microbiology laboratory accreditation will need you to understand the differences between and […] -
Blockchain Innovations that Connect and Protect the Supply Chain
This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s critical supply chain. This webinar will explore the growing use of blockchain in supply chain control. […] -
US vs EU – Medical Devices Compliance and Regulatory Affairs
This webinar will provide an understanding of the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations. We will then discuss the meaning of regulatory compliance from both an internal – company, and […] -
Current Regulatory Requirements for Aseptically Produced Products
The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised. […] -
Pharmacokinetics (PK) / Pharmacodynamics (PD) Studies in Drug Discovery and Development
Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, what the body does to the drug. PK/PD is essential in drug discovery for target validation, optimization of lead […] -
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report […] -
Supplier Quality Management Simplified
Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world. It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations […] -
3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations
To ensure an organization’s quality system has a system to identify product and quality issues; the FDA mandates establishing a process for Corrective and Preventive Action. Any effective CAPA system must include the identification, documentation and review of root causes of problems. Systematic approaches for problem solutions need not only identify but also validate the […] -
4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions
US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that will pass FDA inspection. We will discuss both hardware and software. The newer requirements pertaining to […] -
3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V […]