The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
This classroom course will provide a practical understanding of the following:
It is recommended that course participants have a basic awareness of GxP regulations and/or the use of computerized systems in a regulated environment. Some knowledge of the GAMP approach to computerized systems compliance would be an advantage.
All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.
Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.
Computer system vendors or consultants, engineering contractors, and validation service companies.
Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
This training course is of particular interest to existing and future members of the GAMP®Communities of Practice (COP).
Note: This is offered as a two or three-day course. Please click the "Locations and Registrations" table to select the two or three-day sessions.
|Daily Schedule at a Glance|
|07:00 – 08:30||Registration Open|
|08:30 – 17:00||Training Course|
|10:30 – 11:00||Refreshment Break|
|12:00 – 13:00||Lunch|
|15:00 – 15:30||Refreshment Break|
Not paying by credit card? Use the registration form to pay by mail or by fax.
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, email@example.com.