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5TipsonChoosingaGMPConsultant

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5 T I P S O N C H O O S I N G A G M P C O N S U L TA N T

February 18, 2015 by SeerPharma

Are you a manufacturer working in a regulated environment? Wondering if there is any value on bringing in a
consultant? Start with our 5 best tips on choosing and securing a budget to hire a consultant for your business.
Youre a manufacturer of a product that gets sold and marketed in to a regulated environment. It could be
pharmaceuticals, a medical device or even food. Youve been relatively successful during previous inspections and feel
comfortable with your current QA program but there are new products and processes in the pipeline, and youre not
sure if you have the resources internally to manage an ever changing environment.

Youre not alone. Weve been around for 30 years solving this exact problem for organisations in the Asia-Paci c
region. Building a business case to bring in experienced consultants who can assist is one of the hardest challenges for
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a QA-Manager. Youre thinking Isnt this my job anyway? If I bring in a consultant my bosses will think that Im not good
at my job, or worse yet, my position is redundant.but I need assistance as they look to cut costs and resources for
pro tability
When thinking about external help, most managers will do their best to solveproblems by themselves. In the process,
shaving a few procedures here and there, until a problem arises from an inspection or product failure occurs. Our aim is
to help QA-Managers win the business case to be better resourced and to get you thinking about asking the right
questions, to ensure that your QA processes are watertight and you can be Con dent in Compliance
Here are our 5 best tips to help you win the argument to be better resourced:
Tip 1: Experience matters
Under resourced? As opposed to spending time, money and effort looking for multiple short term xes. It is better to
hire just the one person who can bring a considerable amount of value in a shorter period of time. Greater experience
means less on-board training, plus less of your time diverted from your main task of driving the team in the right
direction. An experienced consultant will hit the road running, and will be able to see the issues even before they arise.
One experienced consultant also means less overhead expenses (eg: WorkCover, Insurance, etc) as opposed to
managing multiple junior external staff.
Tip 2: Bring in the latest best practices from yours and other industries
Experienced consultants are looking at best practices across a variety of industries and are inspired to bring in these
practices whenever possible. This ensures that your processes will always be current. You will get the best ideas
without having to leave the of ce. This in turn will improve your pro le within the company.
Tip 3: Costs understand what constitutes value
Most companies look for a quick short term x and will opt for the cheapest option on the table. We understand that
budgets are tight and xed. However a project is a sum of many parts, and the QA department brings a considerable
amount of value with providing business managers a risk pro le which has a direct impact on future pro tability.
Experienced consultants can help raise the pro le of your department and division so that you can secure a larger
budget, sometimes even immediately.
Tip 4: Assess the reputation of the consultant
Reputations of rms are built on past experiences. Choose a rm with the greatest experience and reputation in your
market and you will be assured that they will work hard to be part of your team. Reputation can be lost in a second, so if
a company has been successful over a long period of time, then you can be even more con dent when employing their
resources. The outcome of the work will be tailored to your teams speci c requirements.
Tip 5: Be Proactive as opposed to Reactive
Most organisations decide to employ a consultant once an issue has arisen. This makes sense from a

nancial

perspective as the problem is known and a budget can be assigned to x the problem. However these costs increase
the risk pro le of the process, plus roll in to the nal cost of manufacturing product, thereby reducing the overall
pro tability of the product and company. Companies often then look to cut xed costs (usually staff) to address the
downward pressures on margin. All in all an effective negative feedback loop.
By employing a consultant early on, risks can potentially be mitigated and a tighter risk tolerance can be applied to the
project as a whole. Thereby giving business heads a more realistic pro tability projection in the future.

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Were happy to sit down with you to discuss the broader view and picture of how consultants can be deployed to assist
you. If youre interested in knowing more, you can get in contact with us.
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Filed Under: QA, GMP, Consultant

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