Webinar Search Results : 39 Upcoming webinars found.
Angela Bazigos Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest Thinking
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Jerry Lanese Friday, February 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Joy McElroy Monday, February 18, 2019
12:00 PM PST | 03:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Joy McElroy
Environmental Monitoring for Pharmaceutical Clean Rooms
This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility Validation data and Post-validation.

Dr. Ludwig Huber Tuesday, February 19, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

David Nettleton Tuesday, February 19, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
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).

Angela Bazigos Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
European Data Protection Regulation - Latest
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

John N. Zorich Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

John C. Fetzer Thursday, February 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Laura Brown Monday, February 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Avoid Significant Fines - Ensure GDPR Compliance for Drug development and Clinical Trials?
The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 it has brought substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

David Nettleton Tuesday, February 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
How to validate software for SaaS-Cloud-Local Hosting
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based approach to COTS software validation minimizes documentation and ensures efficient implementation of new and upgraded computer systems.

Dr. Ludwig Huber Wednesday, February 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Joy McElroy Wednesday, February 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Angela Bazigos Wednesday, February 27, 2019
12:00 PM PST | 03:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Risk Based Service Management and Performance Monitoring for GxP Computerized Systems Operations
This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

Emil W Ciurczak Thursday, February 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Basic Design of Experiments
Traditional batch processing is time-consuming and expensive to perform. With intermediate steps being stored until the following step. A batch not only takes weeks to produce, but there is no control of the process under current GMP. To enhance the control (and the quality) of products, the USFDA issued several Guidances, covering PAT and QbD.

Angela Bazigos Monday, March 4, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

Teri C. Soli Tuesday, March 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Michael Abitz Tuesday, March 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Root Cause Failure Analysis Closed Loop Corrective Action
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Marina Malikova Wednesday, March 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Marina Malikova
Trial Registration and Results Reporting on ClinicalTrials.gov
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).

Dr. Ludwig Huber Thursday, March 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

David Nettleton Thursday, March 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Angela Bazigos Monday, March 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. 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. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Laura Brown Tuesday, March 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
New GCP Compliance Requirements for Clinical QMS (Quality Management Systems)
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.

John C. Fetzer Wednesday, March 13, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Angela Bazigos Thursday, March 14, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Quality Metrics - Latest Advances
This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Joy McElroy Friday, March 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Joy McElroy
Risk Based Approach to Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation.

Emil W Ciurczak Friday, March 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Theory and Practice of Near-Infrared Spectroscopy
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.

Todd B. Graham Wednesday, March 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Todd B. Graham
Effective Ways to Prepare a Standard Operating Procedure (SOP) : Writing, Updating and Maintaining Compliance
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there are no guidelines available by regulatory bodies on how to write, maintain, and update SOPs.

Angela Bazigos Thursday, March 21, 2019
12:00 PM PDT | 03:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.

Dr. Ludwig Huber Wednesday, March 27, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Dr. Ludwig Huber
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Dr. Afsaneh Motamed Khorasani Thursday, March 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Carolyn Troiano Thursday, March 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Angela Bazigos Friday, March 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Joy McElroy Friday, March 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Joy McElroy
FDA Adverse Event Reporting
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries.

Emil W Ciurczak Friday, March 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

Laura Brown Monday, April 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Compliance with the New ICH GCP Revision 2 Addendum - Know the How?
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.

Angela Bazigos Wednesday, April 3, 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 Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

Michael Esposito Wednesday, April 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit.

David Nettleton Thursday, April 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
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).

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