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
Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 & Beyond
The cost of prescription drugs in the United States remains a hot-button issue for policymakers and consumers alike The vast majority of the public sees drug prices as unreasonably high with one in four people taking prescription drugs reporting difficulty ...
- Basic & Intermediate
- 60 Mins
- Dennis Weissman
- Feb 27, 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
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 clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most i ...
- Intermediate
- 60 Mins
- Roger Cowan
- Mar 05, 2019
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer syst ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 06, 2019
USDA Final Genetically Modified Organism (GMO) Label Rule
The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the controversy. After extensive review and industry input, t ...
- Basic & Intermediate
- 60 Mins
- John Ryan
- 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
CAPA Simplified – A One-form, Easy-to-Complete, Method for Simplifying your CAPA Process
This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), e ...
- Intermediate
- 60 Mins
- Denise Wrestler
- Mar 06, 2019