WEBINARS

 

Biotechnology Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

18 / Jun / 2024 - Tuesday

* Per Attendee $199

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

Recording Available

* Per Attendee $249

 

FDA Ambitious Regulation of Social Media and Corporate Responsibility

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Recording Available

* Per Attendee $249

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $219

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Recording Available

* Per Attendee $299

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Recording Available

* Per Attendee $349

 

Proper Execution of Annual Product Reviews

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704993

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Japan: Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702979

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Recording Available

* Per Attendee $299

 

4-Hr Virtual Training: How to Respond to an FDA Investigation

webinar-speaker   Joy McElroy

webinar-time   4 hrs

Product Id: 704549

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Recording Available

* Per Attendee $449

 

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704316

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704313

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

Recording Available

* Per Attendee $299

 

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703066

This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704302

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

Recording Available

* Per Attendee $299

 

Lyophilization Process Development and Cycle Design with a Case Study

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 701961

This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

Recording Available

* Per Attendee $299

 

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 704529

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

Recording Available

* Per Attendee $249

 

Software Validation and its 11 Key Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 703097

This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

Recording Available

* Per Attendee $299

 

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 703644

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

Recording Available

* Per Attendee $299

 

CDISC Mapping 2: ODM, MindMaps and References

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704208

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

Recording Available

* Per Attendee $299

 

Technical Writing for Medical Products: SOPs, Investigations and Change Records

webinar-speaker   Regina Fullin

webinar-time   60 Min

Product Id: 704304

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

Recording Available

* Per Attendee $299

 

1
2 3 4 5

 

 

BEST SELLERS

 

 

 

RECENTLY VIEWED

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method