1. When will the new EU MDR come into effect?
2. How long will we have to make the change?
3. Notified Body Impact.
4. How can Pharmi Med help with the new MDR?
5. QMS Impact of the MDR.
6. What changes are expected from the MDR?
7. Can Pharmi Med help with UDI implementation?
8. How can Pharmi Med help with UDI implementation?

9. When do you need to do Validation?
10. Why do you need to do Validation?

11. Who is responsible for Validation?

12. How much Validation do you need to do?

13. How can Pharmi Med help?

14. Why use Pharmi Med?

15. What good is a template?

16. Should we just use contractors?

17. Why is it better to hire Pharmi Med consultants as opposed to permanent employees?

18. What is needed in a URS document?

19. What is needed in an IQ?

20. What is needed in an OQ?

21. What is needed in a PQ?

22. What is an SOP?

23. What is a FDS, DQ?

24. What is a FAT, SAT?

25. What is GAMP?

26. What is the difference between qualification and validation?

27. What is Software Validation?

28. When should a company use black box testing for CSV as opposed to White Box testing?

29. What is verification and when do we use this?

30. We are setting up a new plant, we need validation services, can Pharmi Med help?

31. We are due an Audit can Pharmi Med help prepare?

32. We need to react to a remediation plan after an audit, can Pharmi Med help?

33. What is Part 11 and Annex 11?

34. What is GxP?

35. What is Gap Analysis?

36. What is a sampling plan?

37. Do we need to use sampling in Validation?

38. What is FMEA?

39. What is six sigma?

40. What is Lean Manufacturing?

41. What is 5S?

42. What is TPM?

43. What is OEE?

44. What is QSR?

45. What is 21 DFR part 820?

46. What is 21 CFR part 210 and 211?

47. What is Annex 15?

48. What is ISO 13485?

50. Can Pharmi Med services be hired anywhere, globally?

 

 

 

Services

Our Validation expertise expand in all arenas from Software Validation to Facility Validation.

Templates

Our tried and tested templates offered throughout the industries have something for everyone from our pay and download section.

Remediation

Pharmi Med Ltd has a multitude of experience with FDA and notified body remediation activities