ComplianceOnline
PAT (Process Analytical Technology): An FDA and Industry Effort
7
/ Apr
Tuesday-2020

PAT (Process Analytical Technology): An FDA and Industry Effort

  • Speaker: Nissan Cohen
  • Product ID: 706370
  • Duration: 90 Min
Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.
* Per Attendee
$249
GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
8
/ Apr
Wednesday-2020

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

  • Speaker: Eleonora Babayants
  • Product ID: 706039
  • Duration: 90 Min
Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP requirements.
* Per Attendee
$249
Aseptic Processing Overview and Validation
9
/ Apr
Thursday-2020

Aseptic Processing Overview and Validation

  • Speaker: Kelly Thomas
  • Product ID: 706212
  • Duration: 90 Min
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
* Per Attendee
$249
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Apr
Thursday-2020

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
* Per Attendee
$249
Handling OOS Test Results and Completing Robust Investigations
9
/ Apr
Thursday-2020

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$249
Data Security in the Current Pandemic of Coronavirus
14
/ Apr
Tuesday-2020

Data Security in the Current Pandemic of Coronavirus

  • Speaker: Eleonora Babayants
  • Product ID: 706446
  • Duration: 60 Min
Data security is the high priority in any organization but especially in regulated industries. Companies need to safeguard against every possible vulnerability across their entire infrastructure. Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other crisis, at this time, more than ever, organizations need to evaluate the potential impact of this crisis on their operations and prepare to deal with pandemic. Crisis preparedness is the high priority in any organization but especially in regulated industries. In a situation when threats are directly impacting important services and assets, time is the most precious resource. Whether it’s a cyber threat or a pandemic, every second counts. In this webinar, we will review crisis preparedness procedures for data security and IT systems. We will look at data governance procedures and how to implement them, how to successfully safeguard data, and maintain the continuity of IT systems operations during crisis.
* Per Attendee
$149
Import Basics to Avoid Detention
17
/ Apr
Friday-2020

Import Basics to Avoid Detention

  • Speaker: Casper Uldriks
  • Product ID: 706358
  • Duration: 60 Min
The webinar will cover requirements for all imported FDA regulated products. Topics covered include required information for FDA’s “Predict” screening program for entry, U.S. Customs Required Information (ACE) program, Harmonized Tariff Schedule, Affirmation of Compliance, and Export Certificate Denial.
* Per Attendee
$229
Crisis Response And Preparedness - Documentation, IT Systems, Data Integrity In The Current Pandemic Of Coronavirus
21
/ Apr
Tuesday-2020

Crisis Response And Preparedness - Documentation, IT Systems, Data Integrity In The Current Pandemic Of Coronavirus

  • Speaker: Eleonora Babayants
  • Product ID: 706455
  • Duration: 60 Min
Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other crisis, at this time, more than ever, organizations need to evaluate the potential impact of this crisis on their operations and prepare to deal with pandemic. Crisis preparedness is the high priority in any organization but especially in regulated industries. In this webinar, we will review crisis preparedness procedures for documentation, data security, and IT systems. We will look at data governance procedures and how to implement them, how to successfully safeguard documents and data, and maintain the continuity of IT systems operations during crisis.
* Per Attendee
$149
Understanding FDA Import Alerts:  What Are They and Recommendations For Removing Your Company And Products From An Alert
23
/ Apr
Thursday-2020

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

  • Speaker: Karl M. Nobert
  • Product ID: 703313
  • Duration: 90 Min
This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
* Per Attendee
$249
Leadership Skills in a GMP Laboratory
23
/ Apr
Thursday-2020

Leadership Skills in a GMP Laboratory

  • Speaker: Rob MacCuspie
  • Product ID: 706423
  • Duration: 60 Min
Scientists are often thrust into leadership roles after demonstrating technical excellence. With a growth mindset, this creates the opportunity to develop leadership skills specific to people management of scientific types. This presentation will highlight how leadership principles apply in a GMP Laboratory environment.
* Per Attendee
$229
Root Cause Analysis - The Heart of Corrective Action
23
/ Apr
Thursday-2020

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$229
Corona Virus - 19:  New Risks with FDA Imports Logistics
28
/ Apr
Tuesday-2020

Corona Virus - 19: New Risks with FDA Imports Logistics

  • Speaker: Casper Uldriks
  • Product ID: 706442
  • Duration: 60 Min
Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.
* Per Attendee
$229
Hazard Analysis and Risk Management under ISO 14971:2007/2012
28
/ Apr
Tuesday-2020

Hazard Analysis and Risk Management under ISO 14971:2007/2012

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.
* Per Attendee
$229
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
29
/ Apr
Wednesday-2020

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

  • Speaker: Carolyn Troiano
  • Product ID: 706348
  • Duration: 90 Min
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.
* Per Attendee
$249
Solving Statistical Mysteries - What Does FDA Want?
30
/ Apr
Thursday-2020

Solving Statistical Mysteries - What Does FDA Want?

  • Speaker: Ron Snee
  • Product ID: 706371
  • Duration: 90 Min

This webinar provides some practical and useful answers to the question

"What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

* Per Attendee
$249
Recorded/CD
When Training is a Root Cause: Handling Investigations of Suspected Performance Issues

When Training is a Root Cause: Handling Investigations of Suspected Performance Issues

  • Speaker: Mike Kent
  • Product ID: 706351
  • Duration: 60 Min
This webinar will discuss handling situations where training has been identified as a root cause during an investigation. Rather than prescribing the all too common, and largely ineffective, re-training event, discover quick and powerful ways to get at what influenced the individual, and how to address these underlying factors to more effectively prevent recurrence.
Recorded/CD
Pharmaceutical Manufacturing Equipment Qualification And Maintenance

Pharmaceutical Manufacturing Equipment Qualification And Maintenance

  • Speaker: Peggy Kwoka
  • Product ID: 706208
  • Duration: 60 Min
Attend this webinar to learn about the GMP requirements for pharmaceutical equipment. Regulations require that equipment is to be of appropriate design, constructed not to alter the product, and properly cleaned and maintained. Demonstrating the adequacy of the equipment starts with a risk assessment and a design qualification and continues through installation qualification, operational qualification, performance qualification and process validation. Preventive and corrective maintenance provide assurance that the equipment will continue to operate as intended.
Recorded/CD
Yes, It's Possible! Tools for Concurrently Enhancing Compliance, Knowledge Transfer and Process Efficiency

Yes, It's Possible! Tools for Concurrently Enhancing Compliance, Knowledge Transfer and Process Efficiency

  • Speaker: Mike Kent
  • Product ID: 706347
  • Duration: 60 Min
This webinar will illustrate a set of unique tools that simultaneously address challenges of improving awareness, accessibility and compliance with process-related information. Learn how to construct solutions that people across your organization can use to better understand how processes work and how their role fits in, all in ways that complement your existing procedures and document structure. You may also find these tools useful when performing investigations, identifying and mitigating potential risks, and describing a process to a regulatory inspector.
Recorded/CD
Beyond the Box-Checking: Strategies for Diversifying Your Ongoing GMP Training

Beyond the Box-Checking: Strategies for Diversifying Your Ongoing GMP Training

  • Speaker: Mike Kent
  • Product ID: 706329
  • Duration: 60 Min
This webinar will illustrate ways to take your ongoing or refresher GMP training to well beyond recycling existing content, regardless of your training budget or available resources. By asking a few simple questions of key stakeholders, and tapping into your already creative process, annual GMP training can start to become more than just something everyone has to complete. Come away with a plan to take your program beyond a year-end box-checking exercise and into a resource that people flock towards.
Recorded/CD
Regulatory Inspections and Quality Audits

Regulatory Inspections and Quality Audits

  • Speaker: Martin Lessem
  • Product ID: 706345
  • Duration: 90 Min
This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.
CD/Recorded
$299
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