Miles Hutchinson Monday
19 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
Miles Hutchinson
$150.00
How to Analyze Financial Statements
How did your business unit perform last year? What's the trend in your key business segments over the last three to five years? How can this information help you identify the key things you need to focus on in the upcoming year? Do you struggle with the language of business? How well do you understand terms like, Top Line Growth, Gross Margin, Gross Profit, Return on Capital, Liquidity, Financial Leverage, EBITDA, Cash flow from Operations, Free Cash Flow, etc.? Grab a cup of coffee and join us to learn how to analyze the numbers and use this intel to juice up virtually every facet of your organization's operations from sales and marketing, to finance, HR, and customer service.

Danielle DeLucy Monday
19 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Danielle DeLucy
$150.00
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

John E Lincoln Tuesday
20 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
John E Lincoln
$150.00
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

David Nettleton Tuesday
20 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 90 Minutes
David Nettleton
$150.00
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Gina Reo Tuesday
20 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Gina Reo
$150.00
New Safe Foods For Canadian Regulation
CFIA is moving quickly to automate their compliance systems, tightening timelines for faster recall and crisis handling while enhancing many of their food safety regulations to compete and sync with global players

Todd B. Graham Wednesday
21 August
, 2019
, 2019
10:00 AM PDT | 01:00 PM EDT
duration 60 Minutes
Todd B. Graham
$150.00
SOP's for Bioanalytical Methods Validation
The webinar will include the following critical information you will need:

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Angela Bazigos
Recorded
View Anytime
$190.00
Angela Bazigos
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Angela Bazigos
Recorded
View Anytime
$190.00
Angela Bazigos
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
With the emerging utilization of computerized technologies in the late 1980s and early 1990s,the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records.

Angela Bazigos
Recorded
View Anytime
$340.00
Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Angela Bazigos
Recorded
View Anytime
$190.00
Angela Bazigos
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.

Angela Bazigos
Recorded
View Anytime
$340.00
Angela Bazigos
3-Hour Virtual Seminar on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
The presentation further describes evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.

Susanne Manz
Recorded
View Anytime
$190.00
Susanne Manz
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

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