The Indian Pharma industry has been under scrutiny over the last few years and has faced audits across the year leading to alarming warning letters being received and facing repetitive audits. This has not only impacted reputation of the companies, but it has become imperative for all pharma companies to bring 24/7 quality culture to become all time audit ready.
This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities.
To ensure that companies successfully pass these inspections there is a need to create a culture of compliance throughout the firm that incorporates on - going preparations and frequent inspection readiness practice.
The workshop guarantees routine success in FDA inspections which would integrate company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspections.
Almost each time, mere mention of the term AUDIT' is enough to raise the level of Norepinephrine HORMONE in our blood and specifically if, Regulatory inspection is from EU or US FDA. The level of such stress is directly proportional to the number of days, we get to breath. Exploding situation is, when the auditor KNOCKS - UNANNOUNCED at the factory gate.
But why do we require to think about PREPARING. Why can't we be EVER READY? Where do we fail? The answer is simple but has different dimensions. The session in the coming two days will address the ways, for every time preparedness for any such INSPECTION, by implementing & monitoring very simple practices.
Though the scope of these regulatory inspections have not changed, but their patterns have certainly changed over the years focussing more on Data integrity, Quality Culture, complaint investigation and handling of Out of specification results .The concept now is Guilty until proven innocent. The advancements in the software industry have raised the platform to enhance the level of operations w.r.t. Data integrity and ensure enhanced levels of compliance.
We know that FDA has set up its offices in India & other countries to assure that the pharmaceutical organizations work within the frame work of cGMP and in line with what has been committed to the Agency through the Dossier. Facing an uninvited auditor and handling the audit successfully, is inevitable for the organizations eyeing for these markets.
The changed scenario requires a simple & strong strategy. This workshop will focus on the areas of concern, which can keep the activities under control and keep us ever ready for any inspection.
- Quality Culture and its impact on audit readiness
- Anytime Readiness (ATR) and its implication
- Understanding auditor's expectation during Unannounced Audits
- Training of shop floor executives to face audits with confidence
- Trends in the current inspection practices by FDA and other global regulatory bodies
Benefit of our Training at your site:
- Will be customized as per your needs
- Convenience and flexibility
- Relevant and Personalized
- Facilitated by experts
- Flexibility of training platform
For more information about this conference visit https://www.researchandmarkets.com/research/wppmfr/unannounced_fda?w=4