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Webinar Search Results : 40 Upcoming webinars found.
Wednesday,
October 17, 2018
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.
Thursday,
October 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
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. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Friday,
October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Evaluating and Selecting a CMO
Pharmaceutical firms must establish clear process of selecting a Contract Manufacturing Organization to perform the selected task or need. It is incumbent on the Pharmaceutical firm, large or small, to develop a criteria for evaluating a CMO. 
Friday,
October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Fundamentals of Calibration and Validation of Laboratory and Process Analysis Instrumentation
How to choose/make standards:
Friday,
October 19, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar - Good Pharmacovigilance Practice
Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. 
Monday,
October 22, 2018
10:00 AM PDT | 01:00 PM EDT
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.
Monday,
October 22, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Laura Brown
2-Hour Virtual Seminar on Data Integrity for GXP Compliance
Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.
Tuesday,
October 23, 2018
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 Process
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
Tuesday,
October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Computer System Validation
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.
Thursday,
October 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Dr. Shuguang Huang
2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:
Friday,
October 26, 2018
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, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k). 
Friday,
October 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.
Wednesday,
October 31, 2018
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
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Friday,
November 2, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar 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.
Tuesday,
November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Tuesday,
November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Tuesday,
November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
ICH GCP Guidelines E6 Revision, R2 Addendum- Changes Impacting Sponsors-CRO-Sites
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.
Wednesday,
November 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.
Friday,
November 9, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Dr. Shuguang Huang
3-Hour Virtual Seminar - Assay Validation According to CLSI Guidelines
Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation.
Friday,
November 9, 2018
10:00 AM PST | 01:00 PM EST
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.
Monday,
November 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Write SOPs which are Compliant for Inspections for a GXP Compliance
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Monday,
November 12, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on 2018 Updates on FDA's Refuse to Accept Policies for 510(k)s and PMAs Including Combination Products
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released updated guidance documents on its policies for refusing to accept 510(k)s and refusing to accept and file reviews for premarket approval applications (PMAs).
Tuesday,
November 13, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
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.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.
Wednesday,
November 14, 2018
10:00 AM PST | 01:00 PM EST
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.
Friday,
November 16, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar Data Integrity in Clinical Trials
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.
Friday,
November 16, 2018
10:00 AM PST | 01:00 PM EST
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.
Monday,
November 19, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Tuesday,
November 20, 2018
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.
Tuesday,
November 27, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - 21 CFR Part 11 - Guidance for Electronic Records and Electronic Signatures used in FDA-Regulated Computer Systems
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Wednesday,
November 28, 2018
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.
Wednesday,
November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
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. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Thursday,
November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Shuguang Huang
Statistics in Non-Clinical Development
In this webinar, I will give an overview of the use of statistics in different non-clinical fields, which mainly include
Friday,
November 30, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.
Monday,
December 3, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Writing Effective SOPs
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Monday,
December 3, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. 
Wednesday,
December 5, 2018
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.
Wednesday,
December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Shuguang Huang
Statistical Quality Control in Pharmaceutical and IVD Industries
Process validation is the establishment of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality characteristics.
Wednesday,
December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry
This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.
Friday,
December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Theory and Practice of Near-Infrared Spectroscopy (NIRS)
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.
Friday,
December 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano 
