Webinar Search Results : 11 Upcoming webinars found.
Angela Bazigos Wednesday, August 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Angela Bazigos Friday, September 6, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Changing your Marketed Device? You Might Need a New 510(k)
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 Monday, September 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Angela Bazigos Thursday, September 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.

Angela Bazigos Tuesday, September 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: 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. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records & Electronic Signatures Rule became law in 1997.

Angela Bazigos Friday, September 27, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Food Facility Inspection
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

Angela Bazigos Friday, October 4, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: 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.

Angela Bazigos Wednesday, October 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: 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 Friday, October 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: 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 Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: 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 Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: 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.

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