Susanne Manz Monday
21 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Susanne Manz
$150.00
Death By CAPA - Does your CAPA Program Need a CAPA?
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Peggy Berry Tuesday
22 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Peggy Berry
$150.00
Raw Materials in Pharma-Biotech Production
This program will address approaches to selecting primary and secondary suppliers of raw materials, developing an incoming receipt and testing process, adequate and appropriate storage, and other considerations for the raw materials used in drug product processing.

John Ryan Tuesday
22 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
John Ryan
$150.00
Traceability and Recall Through Food Processes
This webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.At the end of this webinar, the speaker will handle your specific questions related to the topic.

Allecia Harley Tuesday
22 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Allecia Harley
$150.00
Why Silos are not the Real Problem: Using Warm Hand-offs
Breaking down silos by cross-training employees that have spent years developing expertise in their roles decreases efficiency, job satisfaction, and autonomy.

Steve Gompertz Tuesday
22 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Steve Gompertz
$150.00
The 7 Habits of Highly Effective Project Managers
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.

Swasita Saigal Tuesday
22 October
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Swasita Saigal
$150.00
Managing Complaints, Small Business Perspective
This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.

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Gwendolyn Wise-Blackman
Recorded
View Anytime
$190.00
Gwendolyn Wise-Blackman
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biologic product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems.

Gwendolyn Wise-Blackman
Recorded
View Anytime
$340.00
Gwendolyn Wise-Blackman
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products.

Willy Vandenbrande
Recorded
View Anytime
$190.00
Willy Vandenbrande
Quality for a Sustainable Future
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term. We also give a brief overview of how sustainability has been wrongly tackled in the past.

Willy Vandenbrande
Recorded
View Anytime
$190.00
Willy Vandenbrande
Quality 4.0: Managing Disruptive Change
The feeling is sometimes created that technology itself leads the waves of change. As a consequence, companies look at their IT department thinking that digitization will make the company better and more competitive. But the key to success is to use the right technology at the right time and in the right way.

Angela Bazigos
Recorded
View Anytime
$190.00
Angela Bazigos
FDA's 21 CFR Part 11 Add-on Inspections
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

Angela Bazigos
Recorded
View Anytime
$190.00
Angela Bazigos
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

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