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Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Feb 05, 2020
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
- Feb 06, 2020
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Feb 11, 2020
Adverse Event Reporting and Product Recalls
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...
- Intermediate
- 75 Mins
- Joy L. McElroy
- Feb 12, 2020
Stability Studies and Estimating Shelf Life with Regression Models
Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the ...
- Intermediate
- 90 Mins
- Steven Wachs
- Feb 19, 2020
Acceptance Sampling for Process Validation and Production Lot Monitoring
Personnel involved in process validation and production control often rely on sampling methods to determine the suitability of a process before moving to production (process validation) or for checking production lots for acceptance. This webinar provides deta ...
- Intermediate
- 90 Mins
- Steven Wachs
- Feb 25, 2020
Statistical Methods for Quality Improvement
This webinar introduces important statistical concepts and methods for making objective decisions to ensure and improve product quality. The methods have many applications including: Determining how well my process/product meets requirements Knowing when a ...
- Intermediate
- 90 Mins
- Steven Wachs
- Mar 17, 2020
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Carolyn Troiano
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
Corrective and Preventive Action - Your Most Important Process
While ISO 9001:2015 assigns corrective and preventive action to clauses 8.7 and 6.1 respectively, the same process can handle both activities and support other ISO requirements such as the organizational knowledge data base. It can also be extended to exploit ...
- Intermediate
- 90 Mins
- William A. Levi