What is a Manufacturing Audit?
Companies that manufacture food, beverages, medical devices, pharmaceuticals and cosmetics, must comply with the Good Manufacturing Practice (GMP) regulations. One of the GMP requirements is that these manufacturers regularly undergo GMP audits, often carried out by their foreign partners.
In many cases, interpreters’ help is sought for such audits.
These audits are usually intense affairs, often taking 2 to 4 days, during which the management team of the manufacturing company and the partner’s audit team thoroughly examine a wide range of manufacturing aspects, and go with a fine-tooth comb through a mountain of detailed documentation.
Challenges for the interpreter
A GMP audit assignment is one of the most demanding ones for an interpreter, but at the same time, it can be one of the most interesting. An interpreter gets to visit facilities that are totally out of bounds for ordinary mortals, learn and observe really interesting things. However, there is a lot of complexity involved, considering that the audit deals very deeply with manufacturing processes and technology, company organisation and functions, risk assessment and prevention, and so on. It is very helpful for an interpreter to know what will be expected of them, and how to deal with the challenges of a GMP audit assignment.
What you will learn during this masterclass:
- What GMP means and what aspects it encompasses
- What’s to be expected during a typical GMP audit
- Type of manufacturing facilities that are visited
- Specifics of various manufacturing facilities: food, medical devices, pharmaceuticals, etc.
- Types of documents you will be dealing with
- Considerations of confidentiality and safety
- How to deal with difficulties that will undoubtfully arise during the audit
- How best to prepare for a GMP audit assignment.
Who will benefit from this webinar:
Any interpreter who would like to branch out into GMP work, and also those who have already done it before, but would like to gain a deeper understanding of the demands of a GMP audit and how to deal with them.
If you have any further questions please send them to svetlana@translit.com
