Pharmaceutical
Alternative New and Innovative Pretreatment Technology for Pharmaceutical Water Systems
Pretreatment technology is the first step in pharmaceutical water purification. Pretreatment modules are the preparation of water to be delivered to purification modules of Reverse osmosis, ion exchange, distillation, and micro and ultrafiltration. Poor pretreatment engineering will have a negative impact on the performance of the downstream purification module, causing undue maintenance, costs, and lack of..
An Overview of Ozone, Chemical, and Hot Water Sanitation Methods for Pharmaceutical Compendial Waters
Sanitization is imperative to maintain a very pristine water supply for production purposes. Sanitization is not an absolute value but a reduction in viable bacteria. Sanitization is determined by the logarithmic reduction of the microbials. 103 is considered “sanitization”. 103 - 105 log reduction is designated as “disinfection”.A 106 log reduction is considered “sterilization. It is imperative to di..
Generics - Are Big Pharma and The Generics Industry Enemies or Friends?
A large number of patent battles have been fought between generic companies and originators. Many patent lawyers have retired, having become rich on the fees that they have charged to conduct these court battles - and that can be true whichever side they are working with!However, this webinar is not about the lawyers, but rather about the companies that they represent in court. There have ..
Pharma and Biopharma Application, Market, and Segment Assessments for Ultrafiltration (UF)
Ultrafiltration (UF) is the highest barrier to contamination of the water after generation. UF low molecular weight rejection at 5,000 – 6,000 daltons and small pore size offers the best mechanical barrier to endotoxin carry over. This presentation describes all the filtration issues from larger micron sized used in microfilters to the ultralow nanometer sized filtration. Filtration in the pharmaceuti..
Biosimilars - are they right for you?
The first biosimilar (Omnitrope = somatropin) was registered by the EMA (European Medicines Agency) in 2006. By contrast, the FDA was not able to register any US biosimilars until 2015, when Zarxio (filgrastim-sndz) became the first biosimilar product to receive US approval.Since then, the FDA has been playing “catch-up” so that by mid-2024, the number of US-approved biosimilars was 60 compared to 106..
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..
Effective Batch Record Review
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production an..
Equipment Qualification and Validation of Processes
The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..
FDA/ ICH Guideline Q9 (R1) on Quality Risk Management
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential..
How to Write and Manage a Change Control System
This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.Areas CoveredIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how..
Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
Stability Studies And Estimating Shelf Life With Regression Models
Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will learn different approaches for estimating shelf life and will be in a position to select an appropriate method given the situation and constraints. Participants will learn how to appropriately model the data en..
Stability Testing Of Pharmaceutical Products From Regulatory Perspective
This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. Also, they will be able to de..
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
5S for Operators
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..