WEBINARS

 

FDA 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.

20 / Oct / 2021 - Wednesday

* Per Attendee $199

 

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

20 / Oct / 2021 - Wednesday

* Per Attendee $249

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   75 Min

Product Id: 701582

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

18 / Nov / 2021 - Thursday

* Per Attendee $229

 

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 $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

 

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

 

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705583

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

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

 

Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701461

This software verification and validation training will discuss how to develop / implement formal software Verification and Validation methods for devices, production and test equipment and electronic records / signatures / Part 11 to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters. US FDA, Several standards and industry recommendations will be described in this V&V methods.

Recording Available

* Per Attendee $399

 

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

 

Avoid Documentation 'Time Bombs'

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701407

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.

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

 

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

 

21 CFR 11 Compliance for Excel Spreadsheet

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 702450

This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.

Recording Available

* Per Attendee $249

 

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

 

Writing Effective and compliant SOPs

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 702429

This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.

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

 

 

 

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