| 08.40 - 09.00 |
INTRODUCTION |
| 09.00 - 10.00 |
THE REGULATORS
REQUIREMENTS: WHAT YOU NEED TO KNOW
Computerised systems operating in
the pharmaceutical, biotechnology and medical device industries, as
well as Contract Research Organisations supporting them, are subject
to specific EU and FDA regulations governing computerised systems.
The relevant sections of the regulations will be highlighted and
explained.
- What are the regulations
applicable to computerised systems and network infrastructure:
Good Manufacturing Practice (GMP), Good Laboratory Practice
(GLP), Good Clinical Practice (GCP)
- What are the Electronic Records
and Electronic Signatures regulations (21 CFR 11) and what is
their impact on the IT department?
|
| 10.00 - 11.00 |
COMPUTER VALIDATION -
WHAT IS REQUIRED?
All regulations and guidelines
place the responsibility for computer validation on the end user
management. Quality Assurance and Information Science departments
must help the end user community to ensure that systems are
developed, validated, operated and maintained in a compliant manner.
- The key terms defined and
explained
- Roles and responsibilities
defined and explained: End User, Quality Assurance and IT
- System Development Life Cycle
(SDLC) planning and why is documented evidence important?
- Role of IT in the SDLC and the
importance of regulatory compliance
- Aids to help validation and
qualification: GAMP Guide and PDA technical reports
- Understanding:
- How the FDA carry out
inspections
- Some typical questions you
may be asked
- The results of inspections:
FDA Warning Letters and 483 Observations
|
| 11.00 11.15 |
Break |
| 11.15 - 12.15 |
HOW DO THE
REGULATIONS IMPACT ON AN IT DEPARTMENT?
The FDA's rule of enforcement on 21
CFR 11 now includes the IT Department. This law that brings IT
departments under the new legislation: RAPID ADJUSTMENT TO THE NEW
RULE IS NOW ESSENTIAL.
- Are your computer room
facilities to standard and the environment monitored?
- Do you have procedures and
documented evidence of activities ?
- Do your personnel have current
training records, position descriptions and CVs?
- Do you have security and access
control policie
- Understanding what the
regulators want?
- What minimum written procedures
are required by the regulations
- Do you have them and do you
follow them?
- What is the impact of GXP
regulations on IT operations, especially on change control and
configuration management?
- Do you generate of electronic
records during normal operations
- Are these managed correctly?
|
| 12.15
- 13.15 |
Lunch
|
| 13.15 - 14.15 |
QUALIFYING A NETWORK
AND IT INFRASTRUCTURE
All networked applications run on a
network. Is this adequately designed, installed correctly and
qualified to show how it works? The operational network must be
under change control to ensure that the applications that run on it
remain validated.
- How to define the scope and
boundaries of the network to be qualified
- Documentation of components and
the overall topology
- Managing the cabling contractors
to ensure adequate records of activities
- Initial qualification of the
network and how to proceed
- Change control and the impact of
change on the networks validated applications.
- Advantages and disadvantages of
Common/Standard Operating Environments for the Desktop
|
| 14.15 - 15.15 |
REGULATORY COMPLIANCE
ISSUES THAT MUST BE CONSIDERED WHEN OUTSOURCING YOUR IT OPERATIONS?
Most pharmaceutical companies now
outsource at least some of their IT work. These outsourcing
organisations now fall under new legislation and it is your
responsibility to ensure they are compliant with regulations.
- Does the outsourcing
organisation understand the regulations especially 21 CFR 11?
What to do if they don't. Training and education in the context
of outsourcing
- How to audit the outsourcing
organisation for compliance with regulations before you sign the
contract
- Case studies of auditing
outsourcing
- Inputs required in the service
level agreement for compliance
- When outsourcing can generate
open systems
|
| 15.15 - 15.30 |
Break
|
| 15.30 - 16.30 |
AUDITING IT
OPERATIONS
One of the most important aspects
of ensuring quality is through an audit and IT departments are no
different. Auditing is good way to ensure ongoing quality - knowing
when and how to audit effectively is vitally important.
- How to define the scope and
boundaries of the audit: people, procedures, infrastructure
and/or applications
- How to planing the audit: should
you use a checklist?
- How to execute the audit:
objective facts, not subjective views
- How to report non-compliance and
design, and implement corrective actions
|
| 16.30 - 17.00 |
Discussion
|
| Time
schedule may vary depending on the group being trained. In advance
content can be changed to meet the specific needs of the attendees. |
