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Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.


Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Description :
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Disaster recovery activities often include efforts to deal with both the system functionality and data integrity, quality, accessibility and accuracy.

Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.

The specific tasks and deliverables for both disaster recovery and business continuity must be completed with care toward maintaining a compliant environment.

There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach within a company.
Objective :
This course is intended to provide specific guidelines for coaching attendees on the best practices for Disaster Recovery (DR) of computer systems and data, and for Business Continuity Planning (BCP), including the handling of documentation in the event operations are disrupted. We will discuss the various types of risks, including cyber threats, power outages and others that could render an organization paralyzed in the absence of good planning.
Why You Should Attend :
The attendee will learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of systems and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation, and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff, and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It’s important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.

The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of day-to-day business operations and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation, and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff, and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It’s important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.
Areas Covered in the Session :
  • Gain an understanding of disaster recovery and business continuity planning
  • Develop the ability to apply FDA compliance requirements when developing a disaster recovery and business continuity plan
  • Understand the best practices for developing a disaster recovery and business continuity plan
  • Discuss the best practices necessary to ensure all systems regulated by FDA are protected against disaster and are recoverable in the event disaster strikes
  • Discuss the best practices necessary to ensure all critical business operations can continue uninterrupted, should a disaster occur that causes key systems to become inoperable or inaccessible
  • Understand the importance of preparing documentation that is compliant with FDA requirements
  • Learn about the importance of training, as part of preparation
  • Q&A
Who Will Benefit:
All pharmaceutical, biotechnology, medical device and tobacco companies that are regulated by the FDA or an international equivalent agency
  • American Association of Pharmaceutical Scientists (AAPS)
  • American College of Clinical Pharmacology
  • American College of Clinical Pharmacy (ACCP)
  • American Society for Clinical Pharmacology and Therapeutics
  • Canadian Society for Pharmaceutical Sciences
  • Drug Information Association
  • IAGIM, - Drug Development Association, USA
  • International Academy of Compounding Pharmacists
  • International Pharmaceutical Federation (FIP)
  • International Pharmaceutical Students' Federation
  • International Society for Pharmaceutical Engineering
  • National Pharmaceutical Association
  • Organization of Pharmaceutical Unity with BioAllied Sciences (OPUBS)
  • Pan American Health Organization
  • Pharmaceutical Education & Research Institute (PERI)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Pharmaceutical Research and Manufacturers of America Foundation (PhRMA)
  • Regulatory Affairs Professionals Society
  • Royal Pharmaceutical Society of Great Britain
  • Student National Pharmaceutical Association
  • Society for Biomolecular Sciences
  • Society of Pharmaceutical Education & Research [SPER]
  • University College of Pharmaceutical Sciences
  • World Health Organization (WHO)
About Speaker:
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
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