Effective Training & Development in the Life Sciences
- Speaker:Charles H. Paul
- 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 firstname.lastname@example.org
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
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
All FDA and internationally equivalent regulated industries – Pharmaceuticals, Medical Devices, Cosmetics, Personal Products, Biotechnology, Foods, and Beverages.
- Record Keeping
- Documentation in Regulated Environments
- Developers and Managers
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance/Quality Control
- Marketing & Sales
- Manufacturing and Technical Services
- 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
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.