Drop “outmoded” training to boost GMP compliance; study

By Nick Taylor

- Last updated on GMT

Related tags: Better

Drop “outmoded” training to boost GMP compliance; study
Many biopharma firms can improve their GMP compliance efforts by dropping “outmoded” training measures, a report found.

A Cutting Edge Information survey of compliance teams at 14 biopharma companies, ranging from top 20 firms down to biotechs, found two-fifths use ‘hours per year’ to track training programmes.

CEI is critical of the approach. “Hours per year is an outmoded measure​”,analysts at CEI wrote, “and the fact that it still endures as a popular way to quantify training indicates a process improvement opportunity​.”

A further one-fifth of respondents used the measures ‘hours per month’ or ‘days per year’, leaving 40 per cent of surveyed companies adopting what CEI thinks is most effective: programme completions.

By adopting online training and measuring tracking programme completions firms can, according to CEI analysts, improve the efficiency of their GMP (good manufacturing practice) compliance efforts.

Online training allows compliance teams to track employee performance, have a data trail if an issue arises, and, respondents told CEI, cut the costs and time associated with educating their colleagues.

These positives are particularly pronounced for larger companies which benefit from having a central system to manage tracking of compliance training. Almost two-thirds of the eight top 50 biopharma firms surveyed by CEI use a programme completion model.

Resources also help. “Bigger companies have more resources to pursue automated or proprietary digital training delivery and tracking software and the cost of noncompliance outweighs the cost of such programmes​”, CEI wrote.

These costs are one reason only 17 per cent of surveyed biotechs and medical device companies use the programme completion measure. Biotechs may benefit from reconsidering their approach.

CEI wrote: “Smaller companies should consider improving the compliance training process through such programmes, despite the initial costs associated with implementing them. The alternative is less accountability, less effective training, and potentially, less compliance​.”

Related topics: Processing, Globalisation, Regulations, QA/QC

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