Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss the risks in IV sterile compounding and how to mitigate those risks. We will review the safety requirements in USP <797> and USP <800>, to ensure the safe compounding of CSPs and protection of the patient and compounding staff.

The consequences of an immune response to biologicals, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. Understanding why an immune response is generated, how to detect or predict its generation will help in designing products that will be efficacious and therapeutic.

In response to the global coronavirus pandemic, the UK’s MHRA has published guidance designed to protect the drug supply chain. The scope of the guidance is far-reaching (see below for details) and includes temporary changes to GMP and GDP expectations as well as some licensing arrangements.

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.

This webinar provides some practical and useful answers to the question: “What Strategies Should I Use to Speed Up Formulation Development?” A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.

This webinar will discuss the emergence, lifecycle, biology, transmission, epidemiology, countermeasures of COVID-19. Countermeasures will be broken down into potential treatments that block the viral lifecycle (monoclonal antibodies, Camostat mesylate, chloroquine/hydroxychloroquine, lopinavir-ritonavir, remdesivir); potential anti-inflammatories (corticosteroids and baricitinib); and immune boosters. Testing methodologies will be covered (RT-PCR and ELISA-based). The development path and progress of vaccines will also be covered.

Sampling and sample preparation are both potential sources of variability and bias in analytical chemistry. The purpose of this webinar is to describe a scientifically-sound approach to sampling different types of analytical matrix (including liquids, gases and solids such as powder blends and tablets) and to describe the options available for sample extraction, clean-up and pre-concentration. The webinar would be useful for scientists developing analytical methods or writing sampling plans.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

This webinar will discuss how to properly handle NIOSH listed drugs as per USP <800> requirements from receiving to disposal, including storage, dispensing, manipulation and compounding. Including the proper PPE, deactivation/decontamination required for each handling process.

Attend this webinar to understand how the COVID-19 pandemic can affect manufacturing operations, employee safety and how to be flexible and creative in these uncertain times when it comes to business continuity.

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Prices for some products can vary from around $1,000 per pack in the US to one third of that for the certain product in South East Asia. In EU markets, prices are in between these two extremes and the same product can sell for anything between one-half and two thirds of the US price. The webinar sets out to examine these difference, explain how the price variations have arisen and aims to provide participants with some insights into ways of coping with them when moving into new markets.

Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.

This DMFs (Drug Master File) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.