This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
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).
This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.
The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.
This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology. the webinar willshow when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA / falure investigations, GMP auditing, and liability reduction. Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.
The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.
This webinar discusses applications of normality testing and several issues that may arise when testing data for normality. Several methods for testing data for normality are presented. We discuss some of the common types of goodness-of-fit tests that may be used (e.g. Andersen-Darling, Kolmogorov Smirnoff, etc.). We also discuss common reasons that normality tests are rejected.
PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
This webinar will explain the differences between a GMP audit and a mock regulatory inspection, and will highlight the key considerations for effective conduct of a mock inspection, including problems to avoid.
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.
The objective of this live, interactive webinar is to explore raw materials in a cGMP environment, their various regulatory requirements and how they may affect the timeline of meeting the release date of your Company’s products. Please plan to bring additional personnel to the webinar to obtain cross-Departmental training.
This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system and your technical documentation. Your implementation needs smart ideas to reach the right level to pass the quality management audits and technical documentation audits and review by your notified body.
The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in clinical post market surveillance into your current quality management system according to ISO 13485:2021. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your notified body or authority inspection.