Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This training program will discuss the sources and causes of waterborne disease and what microbial options are available to assess and minimize the risk.

This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.

This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.

Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.

This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.

This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.

This webinar will provide an understanding of the Brazilian market regulatory rules and requirements for cosmetics and personal hygiene products. Attendees will acquire valuable information on the hottest topics allowing them to plan and enter the Brazilian market on a timely and legal manner.

This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.

This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.