This training program will aim to show how best to conduct an ex-US audit and still adhere to the tenets of GxP principles. Should you find yourself enroute to an ex-US audit, do not panic. Many of us have fared through these types of audits in locales where English is not the primary language.
Why Should You Attend:
Being an auditor at an unfamiliar table of hosts is difficult enough when the domain is the US but it can become harrowing when the locale is ex-US. You have to contend with being the foreign entity in the space and having to conduct a detailed review and observation of the host(s) procedures and processes, while not having the full support of the room due to cultural differences or language barriers.
Who Will Benefit:
Clinical program managers
Quality assurance auditors
Anyone involved with outsourced clinical activities
Anyone involved with maintaining global affiliate agreements
Instructor Profile:
Sameer Thapar has extensive experience in operations within the pharmaceutical biotech and CRO industries, with cross-functional experience in medical, clinical, quality compliance and regulatory affairs, and subject matter expertise in pharmacovigilance operations. He has built global regulatory/medical departments as well as run lean organizations while improving efficiencies.
Note:
Use coupon code 232082 and get 10% off on registration.
For Registration:
http://www.complianceonline.com/conducting-audits-in-non-english-locales-ensuring-best-practices-are-followed-webinar-training-704009-prdw?channel=sciencedz