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Technical Writing in the Pharmaceutical Industry
Technical writing in the Pharmaceutical Industry is a highly specialized field. Technical writing differs from general correspondence in that it is written for a specific audience. Technical writing is a balancing act between being precise enough to cover the ...
- Basic
- 60 Mins
- Robert Peoples
- Jul 09, 2020
The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses
In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of low concentrations – impurity and degradation product analyses. Analytically this means identifying these compounds and assessing their amoun ...
- Basic & Intermediate
- 90 Mins
- John Fetzer
- Jul 14, 2020
Proper CAPA Management
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 a ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jul 16, 2020
ETHICS: BEST PRACTICES AND DECISION MAKING
This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties. We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...
- Basic & Advanced
- 60 Mins
- Candace Leuck
- Jul 17, 2020
Implementing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during co ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Jul 21, 2020
Content and Format of an Initial IND submission 21 CFR 312.23
This webinar is designed to help pharma companies through the content and format of every module of the common technical document for an initial IND. The presentation will cover the in depth understanding of the contents of every module in the CTD.
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Jul 21, 2020
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
- Intermediate
- 60 Mins
- Roger Cowan
- Jul 29, 2020
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Advanced
- 60 Mins
- Robert Peoples
Analytical Method Validation and Transfer
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...
- Intermediate
- 90 Mins
- Kelly Thomas
Ten Keys for Maximizing the Benefits of your SPC Program
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC pro ...
- Intermediate
- 90 Mins
- Steven Wachs