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The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Apr 07, 2021
Establishing A Robust Supplier Management Program
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight.All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
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
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
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
Human Error Reduction In GMP Manufacturing/Floor
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. Human errors start at the design stage. From p ...
- Intermediate
- 90 Mins
- Ginette Collazo
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
Fundamentals of Fraud
Fraud is a constant in our lives and must be recognized and eliminated wherever possible.In business, non profit, and business environments it is the responsibility of everyone within an organization to be able to identify fraud. If we do not perform due dilig ...
- Basic & Intermediate
- 90 Mins
- Candace Leuck