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Packaging and Labeling in Pharmaceutical Product Development – Best Practices
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements. Still, their importance is often underestimated, especially in the planning phases, which leads […] -
FDA Regulation of Artificial Intelligence / Machine Learning
AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations and guidance’s. This happens because FDA approves the final, validated version of the software. The point […] -
3-Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months to find you’re device approval has been denied because the software section of the submittal is inadequate and […] -
Successful Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid […] -
Ensuring your Site is Ready for an FDA Inspection
An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided. The FDA continues to write […] -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA […] -
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. […]
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Recording 3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording Effective Genotoxic Impurities Assessment In Drug Development
Residual impurities resulting from the synthetic route, the formulation, or from the degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be administered to patients. Some of these impurities may present... -
Recording How Will FDA’s New Approach to CSV Make Implementations Easier?
There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles... -
Recording Remote Auditing for Medical Device Companies
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID-19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to... -
Recording Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System
This webinar will examine the basic elements of the EU’s QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical... -
Recording 3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording 3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.... -
Recording
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Recording Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Why You Should Attend Training programs have evolved through time. Human reliability or human error... -
Recording
Virtual Site Audits for FDA Regulated Industries
How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites. Each...
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Recording
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording
3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.... -
Recording
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are... -
Recording 3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices
FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for... -
Recording
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... -
Recording
3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
Recording 3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used... -
Recording 4-Hour Virtual Seminar on Preparing and Submitting Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications, and Conducting FDA Meetings
A key role is played by what you submit to the regulatory agency, they hold more than just written applications. They also enclose systematic tracking, editing, publishing and strategy of crucial data. Through precise instructions, case studies and first... -
Recording 3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of...