Search Trainings
Knock, Knock, Who’s There? Preparing for an FDA Inspection
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage i ...
- Intermediate
- 90 Mins
- Susanne Manz
- May 30, 2019
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
- Jun 04, 2019
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 ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Jun 04, 2019
Understanding Human Error in Manufacturing: Methodology for Investigations
As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in manufacturing environments. Sadly, little is known about the nature of these events mainl ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Jun 05, 2019
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Jun 05, 2019
21 CFR Part 11 Conformance for Medical Devices
Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient sa ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- Jun 06, 2019
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, re ...
- Basic & Intermediate
- 60 Mins
- Michael Esposit
- Jun 06, 2019
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jun 11, 2019
New Safe Foods For Canadians Regulation
SFCR consolidates four existing statutes and applies to all food products sold in Canada ensuring truthful labeling while ensuring food manufacturers and importers are responsible for safe, adequately labelled and regulatory compliant products.
- Basic & Intermediate
- 60 Mins
- Gina Reo
- Jun 11, 2019
Risk-based Design Control - The New Paradigm for Medical Device Design
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of th ...
- Intermediate
- 60 Mins
- José Mora
- Jun 18, 2019