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Free Validation Downloads (November-Newsletter)
have encountered many companies that claimed that they operated a ‘no blame
culture’, where employee regulatory compliance is questioned. They in their infinite wisdom seemed to
think this was perfectly acceptable.
The harsh facts are that the regulators expect everyone to be accountable
for their respective actions and are quite prepared (after due legal process) to
demand custodial sentences for serious infringements. We have on several occasions had to edit
client policy documents (in the light of regulatory comments) to reflect that
certain regulatory infringements by staff, would no longer be considered as
minor mistakes and would carry more severe penalties; such as employment
termination and accountability assessment.
Below is an extract from an FDA document regarding CAPA compliance; it is
informative to note how often they refer to the individual’s responsibility and
of the Corrective Action Operating Plan (CAPA) - The corrective action operating
plan should include:
analysis of the audit findings, including an analysis of-all identified
instances of wrongful acts associated with applications submitted to FDA,
identification all individuals who were or may have been associated with or
involved in the wrongful acts, and identification of defective practices,
procedures, products, and applications;
disposition of any recommendations made by the consultant;
description of the actions taken and to be taken to achieve correction of fraud
and other wrongful acts or deficiencies identified by FDA and discovered by the
timetable for implementation of the corrective actions;
of the persons responsible for taking and assuring the satisfactory completion
of each of the corrective actions according to timeframes;
comprehensive ethics program that describes standards for employees and
procedures for educating employees about the program and for enforcing the
procedures for monitoring the effectiveness of the operating plan and to assure
that the applicant can be expected to manufacture products in compliance with
current good manufacturing practices and application requirements.
addition, the corrective action operating plan should establish a mechanism for
assuring that supervisory, technical, and scientific employees are made aware of
the requirements of the Federal Food, Drug, and Cosmetic Act in their area of
responsibility, as well as the requirements under 18 USC 1001.
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