Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This is an advance level webinar that explains how to conduct identity testing of dietary components and what resources are required. It will benefit those who order, purchase, receive, inspect and analyze dietary components. It will also benefit those who have managerial and decision-making responsibilities.

This GMP webinar training will cover the design and implementation of a GMP surveillance program to ensure awareness of and compliance with ever-changing US and international GMP manufacturing regulations, guidance, inspection findings, trends, and related information, and how the process can be used to create GMP training and made even more valuable across the organization in the context of a quality knowledge management platform.

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 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.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

Microorganisms can be found in any aspect of pharmaceutical and, especially, biopharmaceutical manufacturing. Understanding where to look for microorganism and how these are introduced into your process will provide success when being reviewed by an auditor. It is not enough to identify microorganism in your process, but to understand, how, where, when, and why the microbes are in your process. These are questions regulatory auditors will ask when your facility is being inspected.

This VFD Final rule webinar is to give you better understanding what changes apply to you either as veterinarians, food animal producers or distributors.

This webinar will examine the rational use of biopharmaceutical principles to design a drug product that will optimize drug delivery to achieve the therapeutic objectives of the drug.

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 take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

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 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 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.

This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.

This webinar will focus on the USP and FDA requirements for qualification of the dissolution apparatus including guidelines for USP Performance Verification Test and FDA Advanced Mechanical Calibration. It will also provide an overview of USP General Chapters <1058> and <711>.

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.