Webinar - Events

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. Learn how to identify and avoid potential pitfalls during deviation investigations. Why Should You Attend: One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA continues to find fault with investigations and the stated conclusions. The FDA clearly expects that deviation investigations determine what happened, why it happened, and what was done to prevent it from happening again. Investigations also receive detailed scrutiny during FDA inspections. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all ar…

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body. Why Should You Attend: The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes. Those are not only on the classic supplier side. Those are also on the other side of the company in the area of sales and post m…

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers. Why Should You Attend: Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO. This webinar will provide a thorough understanding of the content that…

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. Why Should You Attend: This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data. Areas Covered in the Webinar: Avoid 483s and Warning Letters. Ensure compliance with 21 CFR Part 11 when using Excel spreadsh…

Pharmaceutical packaging and labeling play a pivotal role in the success of any product launch. These activities serve as the essential link between product development and its delivery to the market while ensuring compliance with stringent regulatory requirements. Despite their critical nature, packaging and labeling processes are often overlooked during the planning stages, leading to prolonged cycle times, costly mistakes, delayed product availability, and potential recalls due to noncompliance. This training offers a comprehensive overview of packaging and labeling within the broader context of product development. It equips participants with the knowledge and tools to enhance operational efficiency, reduce errors, and ensure compliance, ultimately contributing to a product's market su…

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.  Why Should You Attend: Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update. This webinar will instruct the participants how to write, maintain, an…

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF. Why Should You Attend: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files (TMF). Areas Covered in the Webinar: Trial Master File (TMF) background and rationale The essential documents to include in a TMF Orga…

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach). Why Should You Attend: This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase producti…

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence. Why Should You Attend: This course will address how to write effective correspondence and reports in support of your company's activities. Attendees will learn how to organize and deliver information for the intended audience. They will also learn how to write clear and readable documents, and h…

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98. Why Should You Attend: Reusable medical devices continue to receive scrutiny from regulatory agencies both in the United States and internationally. Since the advent of ANSI/AAMI ST 98 there has been more clarity in how to perform these validations but it is still important to know the regulatory expectations to reduce the likelihood that submissions will not be accepted and require additional testing or worst case that the testing needs to be repeated. This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of th…

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process. Why Should You Attend: Auditing is a critical function within a pharmaceutical or medical device company. Properly performed audits help to ensure that audited parties are operating in accordance with regulatory requirements, procedures, supply/quality agreements, etc. Ultimately audits are a key contributor in ensuring product quality and regulatory compliance. This webinar will help attendees understand the fundamental audit steps and how to perform them properly. It will focus on audit planning, audit conduct, audit findings, and the audit report. The importance of interview techniques, cr…

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail. Why Should You Attend: This course will offer a broad review of: Different filtration media with the construction characteristics and properties of each detailed A typical pharmaceutical sterile filtration system with its individual components Engineering schemat…

This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach Description: The webinar will discuss in detail how to address the gaps between US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements for: Management responsibilities Device marketing authorization Facility registration Measurement, analysis & improvement Adverse events & vigilance reporting Design and development Manufacturing and service controls Purchasing activities Why Should You Attend: Companies conducting business in various geographical regions have to address numerous s…

Standard Operating Procedures (SOPs) are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. Why Should You Attend: To learn the parameters of an effective SOP To distinguish a well-written SOP from a poorly written one To define processes better by effecti…

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system. Why Should You Attend: An effective change control system is one of the cornerstones of a productive organizational quality system. Change control can be instrumental in ensuring continuous control over changes to facilities, equipment, processes, specifications, and laboratory operations, etc. The importance of change control is emphasized by how it is stressed in regulatory inspections (FDA, EU, TGA, etc.) and in regulatory requirements. There are specific change control elements in cGMPs, ICH, and ISO requirem…

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits. Why Should You Attend: There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate,…

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations. Why Should You Attend: This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. Areas Covered in the Webinar: Which data and systems are subject to 21 CFR Part 11 and Anne…

This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered. Why Should You Attend: All sterile products require some level of sterility during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet expectations or specifications can be critical from a regulatory and safety standpoint. You nee…