Search Trainings
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
- Feb 26, 2019
Best Practice for Complaint Handling in Compliance with FDA and ISO Regulations
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 dete ...
- Intermediate
- 60 Mins
- Jeff Kasoff
- Feb 26, 2019
Equipment Qualification and Process Validation
FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...
- Intermediate
- 90 Mins
- Loren Gelber
- Feb 26, 2019
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
- Feb 27, 2019
Steam Sterilization Microbiology and Autoclave Performance Qualification
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...
- Basic & Advanced
- 60 Mins
- Danielle Delucy
- Mar 06, 2019
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
- Mar 06, 2019
Process Capability Assessment for Normal and Non-Normal Data
Companies must assure that their processes are capable of producing products and services that consistently meet customer specifications. This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for e ...
- Intermediate
- 75 Mins
- Steven Wachs
- Mar 06, 2019
Review of the Changes for ISO 13485:2016 Implementation and Comparison
The International Organization for Standardization (ISO) was established to share knowledge and develop voluntary, consensus-based, market-relevant standards that are designed to help support innovation and to provide solutions to tackle global issues. ISO is ...
- Basic & Intermediate
- 90 Mins
- Erol Ali Cetino
- Mar 06, 2019
Assessing Immunogenicity to Biologics
Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with endogenous pathways in ...
- Basic & Intermediate
- 90 Mins
- Gwen Wise-Black
- Mar 12, 2019
Understanding and Implementing a Quality by Design Program
Understand what is meant by Quality by Design Understand the benefits from applying a QbD approach Provide key steps to implement a QbD program Understand what the important tools used to implement a QbD approach
- Basic & Advanced
- 60 Mins
- Steven Laurenz
- Mar 12, 2019