Auditing Laboratory Data System
Auditing Laboratory Data System
Wilmington, DE
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an unders…
Friday, July 19 2019
9:00 AM
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10:00 AM
Big Data in FDA-Regulated Industry – Best Practices for Systematic Use
Big Data in FDA-Regulated Industry – Best Practices for Systematic Use
Wilmington, DE
In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity to learn about practical, actionable and su…
Friday, July 26 2019
1:00 PM
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2:00 PM
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Wilmington, DE
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behaviour, drive quality culture and improve both individual and company performance. This course will discuss the importa…
Monday, July 15 2019
1:00 PM
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2:30 PM
Writing Effective SOPs for QMS
Writing Effective SOPs for QMS
Wilmington, DE
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…
Tuesday, July 16 2019
1:00 PM
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2:00 PM
4-Hour Virtual Seminar on Aseptic Processing and Validation
4-Hour Virtual Seminar on Aseptic Processing and Validation
Wilmington, DE
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with …
Tuesday, July 23 2019
12:00 PM
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3:00 PM
Strategies for Speeding Up Formulation Development
Strategies for Speeding Up Formulation Development
Wilmington, DE
The life sciences industries are going through tremendous changes that have been increased by the recent global financial challenges. In order to help pharmaceutical and biotech companies improve their operations, the FDA is promoting the use of Quality-by-Design (QbD). Much work has been done on t…
Thursday, July 25 2019
1:00 PM
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2:30 PM
Tips for Dealing With Difficult Customers
Tips for Dealing With Difficult Customers
Wilmington, DE
When you work with the public, you interact with all kinds of people, personalities, and temperaments—all with disparate needs and agendas. As a result, no matter what industry you are in or what kind of service you provide, you’re likely to encounter customers who are difficult to handle. It’s a f…
Thursday, July 18 2019
1:00 PM
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2:00 PM
Toxic Impurities in Active Pharmaceutical Ingredients
Toxic Impurities in Active Pharmaceutical Ingredients
Wilmington, DE
The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients (APIs). Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the pre…
Thursday, July 18 2019
1:00 PM
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2:00 PM
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Wilmington, DE
Clinical trials are expensive, time consuming, and labor-intensive. And in the traditional sense, study designs are inflexible. Adaptive study designs allow for flexibility during a clinical trial. Options can be built into a study to use data collected that has accumulated at interim time points …
Wednesday, July 24 2019
11:00 AM
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4:00 PM
Effective Records Management and Document Control for Medical Devices
Effective Records Management and Document Control for Medical Devices
Wilmington, DE
In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document cont…
Wednesday, July 17 2019
1:00 PM
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2:00 PM