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RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
(Course / Training / Workshop)
INTRODUCTION
Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability.
Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary.
A number of standard tools are available for risk management. Which ones should you use and when?
ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators?
WHO SHOULD ATTEND
This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities:
■ Manufacture or QA of API or drug product
■ Manufacturing rationalisation
■ Site transfer for API and / or drug product
■ GMP compliance
■ Management of regulatory QA / manufacturing QA interfaces
■ Design and construction of manufacturing facilities / processes
■ Validation / Cleaning validation
■ Auditing of own company or supplier
Personnel from the following backgrounds:
■ Production
■ Quality Assurance
■ Engineering
■ Regulatory Affairs Compliance
■ Project Planners
Event Website : RISK MANAGEMENT - Applying it and meeting the Challenges for Industry
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44 1483 730071
