Biotechnology

$200.00
Case Studies on Failed Cycles and/or Formulations of Lyophilized Products

 Recorded Webinar
 60 Minutes
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Case Studies on Failed Cycles and/or Formulations of Lyophilized Products

This webinar will initially give a background on the basics of freeze-dried products and the freeze-drying process. Special attention will be given to the thermal properties of a product (glass transitions, eutectic melts, etc.), and how these properties are affected by heat, residual moisture, and different excipients. Several case studies in failed freeze-dried products due to poorly designed cycles, and ..

$200.00
Cleaning Validation

 Recorded Webinar
 90 Minutes
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Cleaning Validation

This webinar discusses global Cleaning Validation as it is implemented in the pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing health-based Cleaning Validation limits also discussed in this session. Addit..

$200.00
Clinical Process Improvement

 Recorded Webinar
 90 Minutes
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Clinical Process Improvement

Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in cl..

$200.00
CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

 Recorded Webinar
 60 Minutes
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CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -..

$200.00
Comparability Protocols for approved drugs

 Recorded Webinar
 90 Minutes
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Comparability Protocols for approved drugs

This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable the completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.Learning ObjectivesA..

$200.00
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

 Recorded Webinar
 60 Minutes
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Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..

$200.00
Complaint Management: Best Practices to Assure Compliance and Customer Retention

 Recorded Webinar
 60 Minutes
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Complaint Management: Best Practices to Assure Compliance and Customer Retention

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..

$200.00
Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities

 Recorded Webinar
 60 Minutes
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Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities

This presentation is intended as an introductory overview of current industry best practices for minimizing the risk of non-sterile drug product contamination during the manufacturing process. A brief overview of the primary regulatory requirements and industry standards will be presented, (FDA, EU, ISO, ICH, USP, PDA, USP), followed by presentation and analysis of 3 differing approaches for contamination c..

$200.00
Cosmetic Micro Standards, How to Stay in Compliance

 Recorded Webinar
 90 Minutes
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Cosmetic Micro Standards, How to Stay in Compliance

What are cosmetics? Paraphrasing the FD&C Act (The Act), Cosmetics are personal care products applied to the human body for the intention of cleansing, beautifying, promoting attractiveness, or altering the appearance. The operative word here is “intent”. If your products go beyond cosmetic intentions they may also be drugs as defined under the Act: "articles intended for use in the diagnosis, cure, mit..

$200.00
Data Governance for Computer Systems Regulated by FDA

 Recorded Webinar
 90 Minutes
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Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..

$200.00
De Novo Classification Process

 Recorded Webinar
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De Novo Classification Process

Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..

$200.00
Determining a Rational HPLC/UHPLC Selectivity Starting Point

 Recorded Webinar
 90 Minutes
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Determining a Rational HPLC/UHPLC Selectivity Starting Point

Selectivity in a liquid chromatography (LC) separation is the ability to separate a molecule from other similarly structured compounds, such as conformational, positional, and optical isomers. Columns do this in a variety of ways that depend on the structural differences between the key target molecules. This is most commonly done by tailoring the column’s stationary phase so that the different target molec..

$200.00
Developing an Effective CAPA Management and Root Cause Analysis System

 Recorded Webinar
 60 Minutes
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Developing an Effective CAPA Management and Root Cause Analysis System

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..

$200.00
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

 Recorded Webinar
 60 Minutes
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Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..

$200.00
Deviation Management – Investigations to Root Cause Analysis

 Recorded Webinar
 60 Minutes
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Deviation Management – Investigations to Root Cause Analysis

The fundamental failure identified by regulators evolves from companies not knowing how to conduct investigations, how to identify the root cause, and how to select actions to correct the problems such that they never recur. The key to performing effective investigations is the timely gathering of all the facts necessary to understand what happened, and more importantly, what is wrong before we can begin to..

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