Handling foreign inspections in a multicultural environment

Industry field:

Pharmaceutical industry

Seminar description:

In spite of harmonization the Pharmaceutical Industry still need to set aside resources to handle inspections from other parties, both foreign inspectors (i.e. US FDA, TGA Australia, South Korean FDA, Japanese authorities, SFDA (China) and Brazil (ANVISA)) and other actors, i.e. contract givers. This seminar will give you an opportunity to share experience from industry on how to deal with this as efficient as possible.

The presenters will share information that may help API and Dosage form manufacturers to prepare for foreign inspections. With good preparation you can avoid time-consuming follow-up and unnecessary misunderstandings. In the multicultural environment it is important to be prepared so that inspections can be handled efficiently and successfully.

You will also be able to share information about most current topics that are on today's "top list" among auditors/inspectors , such as CAPA systems and supply chain topics.

Seminar outline:

• The approval process and how inspections are planned and triggered

• The differences between a pre-approval inspection (PAI) and routine
   inspections (GMP)

• Preparing for an inspection: key elements that must be covered

• Cultural differences

• Your CAPA systems (Corrective Actions and Preventive Actions)

• Effective investigation of: Complaints, Out-of-specifications and

   Out-of-trends

• Traceability from API/starting material to retail -

   Good Distribution Practices

Who should attend:

Professionals dealing with inspections in companies exporting to countries with no MRA in place will benefit from this seminar. Contract manufacturers selling services internationally will also gain useful information. Production Managers, QC, QA, Materials Managers, Engineering, Utilities Managers, Computerized system Managers and members in a team that deals with inspections at your site, both with direct and indirect contact with the external inspector, i.e. persons in your company that train staff to be prepared.

Course facts

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