Instructor Profile

If you are working in any industry that requires a Quality Management System (QMS), you know that Standard Operating Procedures (SOPs) are a critical part of ensuring consistency, compliance, and safety. However, writing effective SOPs can be challenging, especially when regulatory requirements are constantly evolving.

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. Well-written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well-written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in well-documented and justifiable results.

This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy-to-read and clear SOPs your employees can easily follow. Well-written SOPs ensure that your employees understand and consistently follow your manufacturing processes.

Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality, as well as, in the management of outsourced activities and purchased materials.

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. 

The session provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. 

This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.

The Bacterial Endotoxin Test (BET) is an indispensable safety measure governed by the current good manufacturing practice (CGMP) regulations for pharmaceutical products and medical devices. A comprehensive understanding of this critical release assay, its implementation, and its significance in the production of cGMP goods is critical. It aids in reducing costly errors, batch disposals, expensive failure investigations, and delays in product release, all of which have plagued some manufacturers in the past.

This informative webinar is tailored to provide seasoned technicians with in-depth knowledge of how a Limulus Amebocyte Lysate (LAL) testing program can be leveraged for quality control to conform to regulatory requirements enforced by the FDA and EU.

Your environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles found in critical areas of your operation. 

A vigorous and stringent environmental monitoring program provides you with critical data that assists you in preventing future contaminations. It is critical to ensure compliance with the most recent standards and to drive your productivity forward, with a much lower possibility of having to stop production due to contamination.

This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. 

This webinar will provide different avenues of approach to determine the source of contamination and how to deal with the contamination once the source is discovered.