MASTER
 

Upcoming Events

Webinar Compliance

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.

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.

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 ... read more

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... read more
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Past Events

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 unde...
Friday, July 19 2019 9:00 AM 10:00 AM

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...
Thursday, July 18 2019 1:00 PM 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 p...
Thursday, July 18 2019 1:00 PM 2:00 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 co...
Wednesday, July 17 2019 1:00 PM 2:00 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 c...
Tuesday, July 16 2019 1:00 PM 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 impor...
Monday, July 15 2019 1:00 PM 2:30 PM

Writing Validation Master Plans – Best Practices for Writing a Compliant Document

Writing Validation Master Plans – Best Practices for Writing a Compliant Document

Wilmington, DE
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach t...
Monday, July 15 2019 1:00 PM 2:30 PM

Assay Validation For Clinical Diagnostics

Assay Validation For Clinical Diagnostics

Wilmington, DE
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use. On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practi...
Wednesday, July 10 2019 1:00 PM 2:00 PM

Diversity And Inclusion

Diversity And Inclusion

Wilmington, DE
Diversity and inclusion are hot topics in organizational design and development but are often misunderstood. This course will guide participants through the basic tenants of diversity and inclusion in practice. We will discuss the difference between diversity and inclusion, the differences in in...
Wednesday, July 10 2019 1:00 PM 2:00 PM

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

Wilmington, DE
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia’s C=0) are examined in detail, focusing especially on the...
Tuesday, June 25 2019 1:00 PM 2:30 PM
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