The FDA Guidance for Industry “Process Validation: General Principles & Practices” has been around since 2011, but few firms have fully grasped how FDA is aligning process validation activities with a product lifecycle concept. To integrate these approaches, the 2011 guidance emphasizes the collection and evaluation of data from the design stage through production, to prove your ability to consistently assure product quality. Even with this guidance, some companies still fixate on IQ/OQ/PQ and the “Rule of 3.” This session will help you align your process validation efforts with FDA other modern global guidance docs.
Increasingly, global regulators want to know how effective your Corrective and Preventative Actions (CAPA) are. Investigators will look at this specifically because it will give them a comprehensive window into the steps you take leading up to measuring your CAPA effectiveness. These include Root Cause Analysis investigations, and determining CAPAs. After all, you can’t measure the effectiveness of a CAPA if the CAPA was incorrect to begin with. This webinar will show you how to measure CAPA efficacy AND ensure that you take the right steps to get to that point.
Biocontainment in pharmaceutical manufacturing plays a critical role in keeping patients, personnel, and the general public safe from potentially harmful contaminants. This course will give you a foundational comprehension of the different levels of biocontainment, outline actionable best practices, and leave you with an understanding of key regulatory concerns.
Medical Affairs Organizations are a growing requirement for pharma/biotech firms. However, starting them is never easy. This course will provide an overview of what great Medical Affairs organizations look like, how to build one, and where to start. This is the second session of our comprehensive nine-part certificate series.
As the gap between drug production and the patient shortens, strong Medical Affairs programs are more important than ever. This course will provide an overview of what great Medical Affairs organizations look like, their core activities, and the value they provide. This is the first session of our comprehensive nine-part certificate series.
Global regulatory agencies have the expectation that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA’s findings of deficiencies concerning equipment validation indicate they expect definitive evidence that the equipment meets mandated standards. This interactive session will highlight those standards and provide guidance for efficient, cost-effective qualification and validation programs.
This course will help those using APS/media fills to determine their risks of contamination in the process and how they can prevent it. A complete review of what elements need to be included in the APS design will be discussed, which includes, frequency of performance, number of operators, what types of growth media to use, how slow or fast the filling line needs to operate and how to read the units after they have been incubated.
Sterility investigations are mandated by global health authorities when deviations occur, and are paramount to product safety and efficacy. This session will show you how to conduct effective and efficient sterility investigations that result in proper corrective and preventative action plans (CAPAs).
Compliance with Good Manufacturing Practices (GMP) is a constant source of energy, cost, and stress for pharmaceutical and biopharmaceutical manufacturers, and staying abreast of ever-changing regulations can be a struggle. Plus, as regulators are sharing information and harmonizing approaches, existing data suggests common areas of issues being found by multiple inspectorates.
Though billed as “The End of Validation as We Know it” when released in 2007, the ASTM E2500 standard didn’t quite revolutionize the validation process. Still, even with some limitations, it can be a useful guidance to help make your process more risk-based and efficient. This course will review several case studies that provide key lessons from implementing the E2500 approach over the past ten years.
The pharmaceutical research and development process requires pharmaceutical grade water. If a company cannot meet and maintain legally-required water standards, they cannot sell their products. Training of personnel to assure the water meets and maintains those standards is critical to a company’s success. This course will outline the ways to produce compliant pharma water and increase efficiencies through best practices.
Though often underestimated, Packaging and Labeling has a critical role in the successful launch of a pharmaceutical product. Understanding the packaging and labeling process in the larger product development process will provide any stakeholder an advantage in achieving success.GMP, Marketing, Quality, Regulatory, Packaging, Labeling
Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed.
Quality agreements are an integral part of outsourced GMP manufacturing and testing. Get a fundamental overview of what an effective quality agreement program looks like between you and your vendors and how to manage it.
During process validation, setting your “number of runs” is critical to establishing defensible efforts in the eyes of regulators. This session will give you the tools to tailor that number, plus provide best practices. You will also receive helpful job aids for use long into the future.
Environmental Monitoring (EM) is a critical component to ensuring microbial contamination control in pharmaceutical product development, research, and manufacturing settings. Using a risk-based approach to EM can save money while improving efficiencies and product quality. This webinar will show you how.
