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Amman-Jordan
ACDIMA
A 2-day workshop delivered by renowned expert to understand the
peculiarities for
GxP and Quality Management System Training Activities
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is fundamental in a pharmaceutical quality system which ensures
that
medicines are of the required quality. This training workshop
provides
insights on GMP data integrity implementation aspects for
the
pharmaceutical industry and other regulated environment.
In a very intelligent style, a series of tutorial like sessions
will stimulate your talents to adapt your in-house
systems to a viable compliance state.
Throughout the two-day workshop you will be able to learn
about:
Principles of Data Integrity
Analysis of FDA Warning Letters
Current Regulations and Guidance (EU, FDA, WHO)
Data Integrity Threats
Principles of Good Data Integrity Practice
Data Integrity Analysis of a Business Process
Strategies for Good Data Governance
Audit Trails and Audit Trail Review
System Security Controls
A Programme to Achieve Good Data Integrity
Catch up with the group activity and enhance your experience in
assessing your current compliance state
by joining the :
- Benchmarking Exercise: How do you score yourselves versus Good
Data Integrity Practice?
- Remediation Exercise: Identification of issues and development
of a remediation plan
The data governance system should be integral to the
pharmaceutical quality system. The effort and resource
assigned to data governance should be commensurate with the risk
to product quality, and should also be
balanced with other quality assurance resource demands. As such,
manufacturers and analytical laboratories are
not expected to implement a forensic approach to data checking
on a routine basis, but instead design and
operate a system which provides an acceptable state of control
based on the data integrity risk, and which is
fully documented with supporting rationale.
Register Today!
Agenda is coming soon!
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WHY DATA INTEGRITY AND AUDIT TRAILS ARE NOW BECOMING A TOP
PRIORITY ISSUE DURING
INSPECTIONS?
One of the first regulatory authorities to publish a "GMP Data
Integrity Definitions and Guidance for Industry" was the U.K.
Medicines and Healthcare Products Regulatory Agency (MHRA). New
documents from USFDA, PIC/S and EMA were drafted and, therefore,
“Data Integrity” becomes the New Inspection Focus of the regulatory
authorities. Recently, the number of complaints in Warning Letters
with regard to data falsification and fraud - especially in
analytical GMP laboratories regarding the use of chromatography
data systems (CDS) - has been increasing. Triggered by the cases of
fraud, the requirements for audits of data integrity during
Pre-Approval inspections have been initiated; and inspectors have
been explicitly trained on computer systems and the data they
contain.
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INTENSIVE EMPHASIS ON DATA
INTEGRITY
Good Manufacturing Practice (GMP) data integrity: a
new look at an old topic
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Please fill in the delegate details to apply for the workshop.
Please sign and date then send back to us by
email ([email protected]) and/or fax (009626581649) or you can
fill the information online by visiting
http://acdima.com/en/training/
Early bird registration fee, before 5th December 2016, will be
400 JoD/delegate.
On site, 6th December 2016, registration fee will be 450
JoD/delegate.
Fee should be paid in advance to confirm the full registration.
Priority will be given to the first registrations
on first come first serve basis.
Advance payment to be done by money transfer to the following
address:
Beneficiary: Arab Company for Drug Industries and Medical
Appliances, ACDIMA.
Account No.: 0104437400101001
Bank Name: Housing Bank For Trade and Finance
Branch Name: Park Plaza - Al-Sweifiyeh Amman, Jordan
Bank Address: Al-Sweifiyeh – Salah Sheimat Street – Building
#24.
SWIFT Code: HBHOJOAXXXX
IBAN: JO54HBHO 0260 0001 0443 7400 1010 01
A confirmation email will be sent upon the receipt of the
payment to confirm your registration. Please give
us a call (0096265821618) if confirmation is not received within
48 hours.
Delegate Details
Name:
Affiliation:
Title:
Email:
Tel No.:
Address:
Signature: _____________________ Date: _____/_______/______
Amman-Jordan 6-7 December 2016 ACDIMA
mailto:[email protected]://acdima.com/en/training/
