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..
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..
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..
Advertising and Promotional Material Compliance and Review Process
The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..