1. You have just been hired by a start-up Biologics company as the Sr. Director of the Quality Management System (QMS) and one of the many tasks you will do in your new role is establish an Audit Program.

a) What is a QMS? What is the difference between a QMS, QA and QC? In which area does Quality Audit typically belong? How did the field of Quality Assurance emerge?

b) List 3 functions/things within a Quality Management System (QMS) that can be done to ensure quality.

c) Using the ASQ concepts, explain what is required to establish an effective Quality Audit Program/Department. There should be 8 sections to your answer. please include the following:

-  the overall goal of an audit to the organization (as per ASQ)

-  include who audits are primarily performed for (as per ASQ)

-  2 places where Auditing Department resources can come from

-  at least 1 example of a continuous improvement

-  at least 1 statement about cost, risk or opportunity in relation to continuous improvement (text is critical)

-  at least 1 thing that can impact the long-term planning of an audit program

-  at least 1 way that an Audit program can be evaluated

2. Describe the audit preparation process. Explain each thoroughly not just listing it. Please include the following in your answer:

- 1 example of an audit standard (besides a GxP Regulation)

- 1 way that authority to conduct an audit can be established

- What type of sampling is commonly done in auditing?

- Who signs the Notification Letter and Audit Plan?

3. In 1998 FDA adopted the use of the QSIT in the medical device industry and its subsequent inception in the pharmaceutical industry in 2002. Please obtain and read the pharmaceutical policy and provide a synopsis of what the guidance is about.

Answer only the following information and please letter your responses a - j:

a) History/background (where did the program originate from?)

b) Brief comparison of FDA's traditional inspection approach vs. this guidance (3-4 sentences at the most)

c) What type of inspections is the program used for, what are the program systems & what system is required in every inspection?

d) The audit strategy, options used and an example of when each option can apply

e) If an option is static once selected or if it can be changed during an inspection

f) What regulations the policy is used to assess compliance against

g) What is a profile class and an example of one?

h) 2 benefits of the program to the FDA

i) 2 benefits of the program to industry

j) Inherent compliance and quality assumptions/risks of the program (at least 1)