Effective Training & Development in the Life Sciences

  • Speaker:Charles H. Paul
  • Duration:90Min
  • Product Code:GRC-90410

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

This Training is available for On Site and Corporate Training

Certification:

GRCTS Completion Certificate

About the topic: 

Training and documentation within the Life Sciences are inextricably linked together into an integrated system that combines “Best Practices,” regulatory compliance, principles of human performance, and adult learning to achieve the most favorable outcome of superior worker performance and the achievement of compliance excellence.

Training is the process by which individuals acquire skill and knowledge.  There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness.  Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training.  Read and Understand is a technique that is and has been extremely abused in the training field within regulated industries for many years because it is cheap and requires the minimum expenditure of the organization’s resources.  The problem with this approach is that it is totally inappropriate for the majority of situations in which it is applied.  From a regulatory standpoint this is extremely important to know because ineffective training within regulated industries equals a potential for compliance deficiencies. 

Regulatory compliance documentation on the other hand, is the process by which key critical tasks are or should be documented within our Life Sciences businesses.  What is Regulatory Documentation and what role does it play in this process? 

Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide.  Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc.  The key is to knowing how to write those documents to properly meet those needs.  In addition, the significant relationship between compliance documentation and training has not escaped regulatory scrutiny.  When regulators look at documentation they also look at training in terms of the individuals to which the documentation applies and vice versa.      

Why you must attend this webinar: 

Writing effective Standard Operating Procedures and Work Instructions and developing training to support those documents is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

This webinar will also explore the area of training in regulated environments, its importance, and its relationship to compliance documentation.  Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing within regulated industries – foods, cosmetics, beverages, medical devices, pharmaceuticals, biologic, etc. Yet, training is equally as important as any compliance discipline.  The major problem today is how training is applied, how training is administered, and how training is managed within the modern regulated industry.  We will look at Best-in-Class applications of training and how training can significantly contribute to not only world-class compliance but improved operational performance, improved quality, and improved employee/associate safety.  And how together, effective documentation and training can significantly improve your operations.

Areas we will be Covering:

  • Global regulatory requirements for compliance documentation and training
  • The relationship between compliance documentation and training
  • Read and understand versus demonstrated competence
  • Elements of a compliant documentation and training system
  • How to conduct a compliance documentation and training analysis
  • Compliance documentation and training as the basis for world-class operational control and performance improvement

Who will benefit: 

Anyone having responsibility for Training and Compliance

  • Record Keeping
  • Documentation in Regulated Environments
  • Developers and Managers 
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance/Quality Control
  • Compliance
  • Marketing & Sales
  • Manufacturing and Technical Services
  • Engineering
  • IT/MIS
  • Executive Management
  • Laboratory Operations
  • Customer Service
  • Clinical Research managers and personnel
  • Specialists/SMEs in all departments
  • QA/RA managers and personnel
  • Quality System auditors
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Consultants
All FDA and internationally equivalent regulated industries – Pharmaceuticals, Medical Devices, Cosmetics, Personal Products, Biotechnology, Foods, and Beverages.

Instructor:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.  Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject.  The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

Available Options

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,659

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,759

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$809

Related Products

510(K) Submission - A Comprehensive and an Updated Overview

510(K) Submission - A Comprehensive and an Updated Overview

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Use coupon code "GRCTS10" to avail a 10% Discount on your purchaseCertifications: GRCTS Attendance CertificateWhy should you attend:The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket no..

$269

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

Root Cause Analysis and CAPA

Root Cause Analysis and CAPA

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Use coupon code "GRCTS10" to avail a 10% Discount on your purchaseCertification: GRCTS Completion CertificateDescription: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your C..

$259

Understanding the US FDA Drug Review and Approval Process

Understanding the US FDA Drug Review and Approval Process

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification: GRCTS Completion CertificateWhy you must attend: The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) ..

$259

Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description: Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. M..

$249

Comparing GLP with GMP

Comparing GLP with GMP

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also signific..

$269

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

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

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance Certificate -Background: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 proje..

$259

How to Conduct a Human Factors/ Usability Validation

How to Conduct a Human Factors/ Usability Validation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:This webinar will explain the procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success crite..

$259

Qualification of contract manufacturer organizations based on practical experience

Qualification of contract manufacturer organizations based on practical experience

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Why should you attend:Regulatory agencies require that companies carefully select suppliers and contract manufacturers? The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMODes..

$289

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types ..

$269

Medical Device Recalls – A Complete Prevention Strategy

Medical Device Recalls – A Complete Prevention Strategy

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Topic Description:In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 attributable to a variety of reasons.  Whatever the reason, medical device recalls are ex..

$259

Preventing Human Error in the Life Sciences

Preventing Human Error in the Life Sciences

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification - GRCTS Attendance CertificateBackground:       This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human ..

$269

US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance CertificateTopic description:  This webinar will discuss all aspects of the US FDA Pre-Submission process.  This webinar will review when a Pre-submission may be appropriate for a compan..

$259