ABSTRACT
Rarely does everything go exactly to plan. Practitioners should be prepared to deal with unforeseen issues that potentially compromise the regulatory compliance being sought. This chapter shows how risk-based thinking might be employed to resolve common issues. However, in presenting this offering we need to emphasize that the individual circumstances may change what is appropriate and acceptable. As consultants would say “It depends”! Practitioners need to use their regulatory knowledge and judgment to deem what is suitable or not. The needs of the pharmaceutical and healthcare company will vary based on many different factors.
