Event Calendar

01 December 2016

Emirates Airline Dubai Rugby Sevens 2016

(73997)
  • Emirates Airline Dubai Rugby Sevens 2016
    Emirates Airline Dubai Rugby Sevens 2016  Emirates Airline Dubai Rugby Sevens 2016

Venue: 

The Sevens Stadium

Date: 

01 December 2016 to 03 December 2016

Address: 

Dubai

Description: 

The Emirates Airline Dubai Rugby Sevens is back and promises to be even bigger and better than ever. The best players in the world will converge on The Sevens stadium for the three day annual rugby extravaganza with awesome action and entertainment on offer, and fantastic fun activities for the whole family.

Ticket price
1 December : Free
2 December : AED300 onwards
3 December : AED300 onwards
Season Ticket : AED500

Master HIPAA Compliance in Six Steps

(73833)
  • Master HIPAA Compliance in Six Steps
    Master HIPAA Compliance in Six Steps Master HIPAA Compliance in Six Steps

Venue: 

The Doubletree Baltimore-BWI Airport

Date: 

01 December 2016 to 02 December 2016

Time: 

9:00 AM - 6:00 PM

Phone: 

+971-18004479407

Website: 

http://bit.ly/2eeYBpy-Master-HIPAA-Compliance

Address: 

890 Elkridge Landing Road
Linthicum
21090

Description: 

Overview:
The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them.
Seminar Takeaways:
Thorough Understanding of HIPAA Rules
• What they are
• How they work together
• Why and How they were made
• How they are changing and what to expect next
HIPAA Risk Analysis - Risk Management for Your Organization
• A Practical Guided Exercise done in class on your computer to take home
Privacy and Security Rules - Permitted and Required Uses and Disclosures
• What information must be protected
• Administrative, Technical and Physical Safeguards
• Social Media, Texting and Emailing Patients
The inter-connected, inter-dependent relationship of Covered Entities and Business Associates
• Business Associate HIPAA compliance responsibilities
• The importance of Due Diligence and how to do it
• How to avoid making a Business Associate your Agent by mistake
• The chain of responsibility from Covered Entity to Business Associate to Subcontractor Business Associate, etc.
• Business Associate responsibilities for Subcontractor Business Associates
• Breach Notification discovery and reporting by Business Associates and Subcontractor Business Associates
What is - and what is not a Reportable Breach of Unsecured PHI
• Potential Breach Investigation - Breach Exceptions
• Ransomware
• Breach Risk Assessment
• Breach Prevention
Who will benefit:
• Health Care Provider - Business Associate
• Health Care Provider Practice Manager
• Risk Manager - Compliance Manager
• Information Systems Manager
• Compliance Director
• Practice Manager
• Privacy Officer
• Security Officer
• CEO
• CFO
• COO
• Chief Information Officer
• Health Information Manager
• Healthcare Legal Counsel
• Office Manager
• Contracts Manager
• Chief Clinical Officer
• Human Resources
Agenda:
Day 1 Schedule
Lecture 1:
• HIPAA Overview - HIPAA Compliance Fundamentals
• HIPAA explained in plain language
• 6 Basic HIPAA Compliance Policies
Lecture 2:
• HIPAA Risk Analysis - Risk Management The basis of your HIPAA Compliance Program
• Learn by Doing You will do a guided Step-by-Step HIPAA Risk Analysis - Risk Management of your organization on your tablet/laptop - for you to take with you
Lecture 3:
• Finish HIPAA Risk Analysis - Risk Management
• Consider lessons learned
• How might you improve your HIPAA Compliance Program?
Lecture 4:
• Privacy Rule
• Protected Health Information (PHI)
• Permitted Uses and Disclosures of PHI
• Social Media
Day 2 Schedule
Lecture 1:
• Security Rule
• Electronic Protected Health Information (EPHI
• Permitted Uses and Disclosures of EPHI
• Security Official Duties
Lecture 2:
• Business Associates
• Inter-connected HIPAA Compliance for Covered Entities and Business Associates - Agency
• Due Diligence
• Subcontractor Business Associates
• Business Associate Agreement
• Non-BA Confidentiality Agreement
Lecture 3:
• Breach Notification
• Learn by Doing Investigate a Potential Breach
• Do a Breach Risk Assessment
• When you must notify - and when you do not need to notify
• Notifications and Documentation
Lecture 4:
• Install or Update Your HIPAA Compliance Program
• Workforce Training
• How to prepare for HHS Audits or Investigations
• Final Questions - Answers
Speaker:

Paul R. Hales, J.D.
Paul R. Hales, Attorney at Law, LLC
Paul R. Hales received his Juris Doctor degree from Columbia University Law School and is licensed to practice before the Supreme Court of the United States. He focuses on HIPAA Privacy, Security, Breach Noti?cation and Enforcement law. Mr. Hales conducts a national HIPAA consulting and education practice based in St. Louis. He is the author of all content in The HIPAA E-Tool®, an Internet-based, complete HIPAA Software as a Service product for health care providers and business associates.

Location: Baltimore, MD Date: December 1st & 2nd, 2016 and Time: 09:00 AM to 06:00 PM

Venue: The Doubletree Baltimore-BWI Airport
Address: 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate – without stay)

Until October 20, Early Bird Price: $1,295.00 from October 21 to November 29, Regular Price: $1,495.00

Price: $1,695.00 (Seminar Fee for One Delegate – with stay)

Until October 20, Early Bird Price: $1,695.00 from October 21 to November 29, Regular Price: $1,895.00
Register for 5 attendees (With stay) Includes Price: $4,323.00 $8,475.00 You Save: $4,152.00 (49%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2eeYBpy-Master-HIPAA-Compliance
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

Validation and Part 11 Compliance of Computer Systems and Data – GlobalCompliancePanel 2016

(73747)
  • Validation and Part 11 Compliance of Computer Systems and Data – GlobalCompliancePanel 2016
    Validation and Part 11 Compliance of Computer Systems and Data – GlobalCompliancePanel 2016 Validation and Part 11 Compliance of Computer Systems and Data – GlobalCompliancePanel 2016

Venue: 

Hilton Zurich Airport

Date: 

01 December 2016

Time: 

9:00 AM - 6:00 PM

Phone: 

+971-18004479407

Website: 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900692SEMINAR?SEO

Address: 

Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg
Switzerland
8152 Dubai

Description: 

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are on target of inspectors. The large numbers of FDA warning letters also demonstrate that the industry struggles with either understanding or implementing the regulations.
This 2-day interactive course provides the regulatory background and guides attendees through the complete equipment qualification and computer system validation processes from planning to reporting. It also helps to fully understand not only the text but also the meaning of Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used by attendees to easily implement what they have learned in the course.
Course Objectives:
• Learn about the FDA requirements for equipment qualification according to Annex 15, USP <1058>, and computer system validation according to GAMP Guides
• Learn which equipment/systems need to be qualified or validated
• Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
• Understand each step and practices of instrument qualification and computer system validation
• Understand how to archive raw data from hybrid systems: electronic vs. paper
• Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
• Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
• Understand FDA's New and ongoing Part 11 inspection and enforcement practices
• Be able to develop inspection ready documentation during on-going routine operation
• Learn how to avoid and/or respond to FDA inspectional observations and warning letters
Who Should Attend?
• IT/IS managers and system administrators
• QA managers and personnel
• Laboratory Managers and Supervisors
• Analysts
• Validation Specialists
• Software Developers
• Regulatory Affairs
• Consultants
• Documentation Departments
• Training departments
From
• Pharmaceutical development and Quality control laboratories
• Quality control laboratories of API manufacturers
• Contract laboratories
• Contract manufacturers
• Clinical Research Organization
• Suppliers and service providers of instruments and computer systems
Agenda:
Day 1 Schedule
Lecture 1: Requirements and approaches for Instrument Qualification and Computer System Validation
• FDA/EU, ICH and PIC/S requirements
• Lessons from recent FDA Warning Letters and how to avoid them
• Understanding the terminology: qualification, calibration, verification, validation.
• EU/PUCS GMP Annex 15: Validation and Qualification
• USP Chapter <1058> for analytical instruments: current and proposed changes
• Lessons from GAMP®5 and from the GAMP® guide: "A Risk based Approach to Laboratory Systems"
• Planning for cost-effective qualification and validation
• Which instruments require qualification/validation
Lecture 2: Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
• Objective, scope, current situation and future of Part11
• Requirements overview and spirit of the regulation
• Requirements for electronic records
• Requirements for electronic and digital signature
• Additional requirements from the PICS/EU Annex 11, from the UK MHRA and from the WHO GMP data integrity guidelines
• FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters
• User requirements for Part11/Annex 11 based on risk
• Upgrading old or purchasing new systems: compliance and business aspects
• Six steps for implementation of Part11/Annex 11
Lecture 3: Going through the equipment qualification phases
• Develop a project plan from the master plan
• Writing requirement specifications
• Documenting installation and installation qualification
• Testing for initial operational qualification
• Preparing and executing test protocols
• Maintenance, requalification and change control
Lecture 4: Cost Effective Validation of Computer Systems: Step-by-Step - Part 1
• Selecting the right validation lifecycle model
• Going through examples of a complete computer system validation from beginning to end
• How risk assessments can help to determine the type an extent of validation
• Defining user requirements based on risk
• Vendor assessment and supplier agreements
• Going through examples for OQ and PQ testing
• Writing the validation report
Day 2 Schedule
Lecture 1: Validation of Computer Systems - Part II
• Leveraging validation efforts of identical systems
• Validation of existing equipment and computer systems
• Preparing inspection ready validation documentation
• Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
• IT infrastructure qualification and validation of networked systems
• Validation and use of cloud computing in FDA/EU regulated environments
• Recommendations for different cloud models and services
Lecture 2: Validation and control of Excel spreadsheet applications
• Designing spreadsheets for compliance
• Validation approach for spreadsheet applications
• When, what and how much to test?
• Recommendations from GAMP®5 for testing native Excel functions
• How to ensure spreadsheet and data integrity
• Going through examples
• Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody
Lecture 3: Maintaining the validated state of computer systems or Control of Operation and Retirement
• Ongoing training of users and IT staff
• System maintenance and data backup
• Change control: Handling planned and unplanned changes
• How to deal with security patches
• Periodic review vs. revalidation
• Disaster recovery and business continuity planning
• Retirement of computer systems and data migration
Lecture 4: Ensuring and documenting Integrity of Laboratory (Raw)data and other Records
• Learnings from the new FDA guide: Data Integrity and GMP Compliance
• Definition of raw data and meta data: FDA/EMA requirements
• What to archive for hybrid systems: paper records or electronic records
• The importance of electronic audit trail to document data integrity
• Review of electronic audit trail: who, what, and how
• How to ensure availability of electronic records throughout the entire retention period
• Steps for validating security and integrity functions
• Examples how to ensure and document data integrity and security
• Preparing your company for data integrity audits
Speaker:
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Labcompliance

• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
• Presenter of the Year of the Institute for Validation and Technology
• Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
• Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
Location: Zurich, Switzerland Date: December 1st and 2nd, 2016 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price: Register now and save $200. (Early Bird)
(Without Stay) Price: $1,695.00 (Seminar for One Delegate)

Until October 15, Early Bird Price: $1,695.00 from October 16 to November 29, Regular Price: $1,895.00

(With Stay) Includes Price: $2,095.00 (Seminar for One Delegate)

Until October 15, Early Bird Price: $2,095.00 from October 16 to November 29, Regular Price: $2,295.00

Register for 5 attendees (With stay) Includes Price: $5,343.00 $10,475.00 You Save: $5,132.00 (49%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=...
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

Sixth International Research Conference on Engineering, Science and Management 2016 (IRCESM 2016)

(72119)
  • Sixth International Research Conference on Engineering, Science and Management 2016 (IRCESM 2016)
    Sixth International Research Conference on Engineering, Science and Management 2016 (IRCESM 2016) Sixth International Research Conference on Engineering, Science and Management 2016 (IRCESM 2016)

Venue: 

Hyatt Place Hotel

Date: 

01 December 2016 to 02 December 2016

Time: 

8:00 AM - 3:00 PM

Phone: 

+971-0503498072

Website: 

http://ircesm.org/

Address: 

Al Rigga
Dubai
128405 Dubai

Description: 

Sixth International Research Conference on Engineering, Science and Management 2016 (IRCESM 2016), is a premier event in the field of Engineering, Science and Management. This multidisciplinary Conference will be held in Hyatt Place Hotel, Al Rigga, Dubai, UAE during 1st & 2nd December 2016.

6th International Conference on Innovative Trends in Science, Engineering and Management 2016 (ICITSEM 2016)

(72117)
  • 6th International Conference on Innovative Trends in Science, Engineering and Management 2016 (ICITSEM 2016)
    6th International Conference on Innovative Trends in Science, Engineering and Management 2016 (ICITSEM 2016) 6th International Conference on Innovative Trends in Science, Engineering and Management 2016 (ICITSEM 2016)

Venue: 

Hyatt Place Hotel

Date: 

01 December 2016 to 02 December 2016

Time: 

8:00 AM - 3:00 PM

Phone: 

+971-0503498072

Website: 

http://www.icitsem.com/

Address: 

Al RIgga
Dubai
128405 Dubai

Description: 

6th International Conference on Innovative Trends in Science, Engineering and Management 2016 (ICITSEM 2016), is a premier event that address the new advancements and challenges in the field of Science, Engineering and Management. This Multidisciplinary Conference will be held in Hyatt Place Hotel, Al Rigga, Dubai, UAE during 1st & 2nd December 2016.