Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions

The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.

This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.

Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.

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.