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What is Data Trending and How To Identify, Action and Report Trends

The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.

Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems.  By night he works on his science chops.  He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading

Question regarding Bacillus subtilis recovery when testing for absence of Salmonella sp.

The Question posed on LinkedIn:

Dear experts, During microbial contamination testing for specific organisms – salmonella growing was observed. identification shows that is not Salmonella, but Bacillus subtilis. How i shoud interprated the results, pass specification or not?

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Interview Questions Asked of Me

The recommendation is to answer these questions using the STAR format.

  • Situation: Describe the situation pertaining to the topic of discussion or the interviewer’s query.
  • Technique: Explain the technique you used, your approach.
  • Action: Emphasize the action you took to solve the situation.
  • Result: Close with the result or outcome of the action taken.

I prefer the CAR format as it is pretty much the same, but IMO, more efficient.

  • Context: What situation were you in? What background information does the listener need to understand the context? What was the task you were expected to perform? What needed to be done? What challenges did you expect to face?
  • Action: What actions did you take? (You can also outline what alternatives you considered.)
  • Result: What impact did your actions have? (These do not have to be all puppies and rainbows. You can admit that you got it wrong on the first try and had to go back and fix something.)

What follows are questions I have been asked during interviews

  • Tell me about yourself, your background.
  • Where do you see yourself in five years? Ten years?
  • What are your career goals?
  • Give us a brief rundown on your qualifications and employment history
  • What are you qualifications for the position?
  • What can you bring to this position?
  • What are your strengths and weaknesses?
  • What are your greatest accomplishments?
  • What qualifications do you have that make you think that you will be
    successful in your field?
  • What did you like best/least about your other jobs?
  • What gives you personal satisfaction?
  • Delegated a project or job effectively
  • Adapted to a new and difficult situation
  • Had to make an unpopular decision
  • Handled a difficult situation with a co-worker
  • Made a bad decision / mistake
  • Worked effectively under pressure
  • Provide an example of when you have been responsible for or driven change
  • Describe your ideal job
  • Describe your ideal manager
  • What qualities should a successful manager possess?
  • Describe the best supervisor you’ve ever had
  • What do you consider to be your greatest strengths and weaknesses?
  • How would a good friend describe you?
  • Do you prefer independence or a team structure?
  • What kind of supervision do you prefer? What qualities in a supervisor do
    you like most?
  • How do you handle instructions and criticism?
  • Are you willing to relocate for the job?
  • What do you know about us?
  • Why do you want to work for us?
  • How can you make a contribution to our organization?
  • What job in our organization would you choose if you were entirely free
    to do so?
  • What interests you about our product or service?
  • Why are you applying for this job?
  • What is your understanding of the nature of the job and the company?
  • How do you determine or evaluate success?
  • Do you consider yourself a leader?
  • What are the attributes of a good leader?
  • Describe the workload in your current (or most recent) job.
  • Describe what you do in a day (Tell us about your previous supervisory experience.  What does it involve?)
  • Which is more important: creativity or efficiency? Why?
  • What two or three accomplishments have given you the most satisfaction? Why?
  • When have you felt proud of an accomplishment at work?
  • When have you made a positive contribution in your job?
  • How do you work under pressure?
  • What do you enjoy most about supervising?
  • What do you enjoy least about supervising?
  • What’s one of the hardest decisions you’ve ever had to make?
  • What is the hardest decision you have had to make / thing you had to do as a supervisor?
  • Tell us about your decision making skills
  • Tell us about your problem solving skills
  • What have you accomplished that shows your initiative?
  • How do you motivate others?
  • What would you do to establish your authority in this this position with your peers?
  • What would you do to establish your authority within our facility?
  • Tell us about how you meet deadlines. How do you deal with unreasonable deadlines
  • How have you dealt with a difficult manager or team member?
  • How would you deal with a poorly performing team?
  • How would you deal with a poorly performing team member?
  • What Evidence of resolving conflicts do you have?
  • Detail situations that required you to use your negotiation skills
  • How do you motivate employees, including those you are not directly responsible for?
  • How have you dealt with a major problem?
  • Talk us through your experience working with testing samples in a lab and quality testing?
  • Talk us through your recent Manufacturing or Quality technician experience that is relevant to this role?
  • What motivated you to apply for this role?
  • What techniques do you use to manage time / people?
  • How do you exchange information within your team / with customers / with other departments?
  • What were your achievements in you last/current position (or place of employment)?
  • Why are you best suited to this position? / Why should we employ you in this position? / What in your background indicates you’re prepared for this position?
  • Tell me a time where you made a mistake. What happened, how did you react, and what was the result?
  • Tell us about a situation where you made a decision you later regretted / would make a different decision.
  • What have you learned from your mistakes?
  • When have your technical skills been challenged?
  • When have your supervisory skills been challenged?
  • Once an issue has been identified, how did you resolve it and ensure that it did not occur again?
  • What makes you think you would be suited for a quality assurance associate role?
  • What have you done to prepare yourself for a quality assurance associate role?
  • Tell us about Good Manufacturing Process
  • What in your own words, defines quality / is quality?
  • What are the 3 changes you would implement immediately / (if currently working at company where interview is) What has prevented you from making these changes already?
  • What do you know about <company you are interviewing for>

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Controlled Documentation. Identifying what goes into a Policy, a SOP and an OI

The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.

I am a microbiologist with over 15 years’ experience in the pharmaceutical realm.  I have a strong interest in regulatory compliance, documentation and developing others.  Recently I have been working closely with data security.  I have an arty streak, have developed and delivered training and have an affinity for computers.  I ride bicycles…a lot.

Controlled Documentation.  Identifying what goes into a Policy, a SOP and an OI Continue reading

Question Regarding Time Stamps

The Question posed on LinkedIn:

Hello Dear LinkedIn friends. I have few questions related to computerized system.

1. In a country where there is a change in time due to day light saving. How does audit trails and reports are managed in software? ( Here software is operated in multiple time zones) Example: if someone logs in at 9:55 AM and start activity which lasts for 15 mins (means completion at 10:10). What if, in between there is day light saving happened at 10 AM and time goes 1 hr back. It will show that personnel logged in at 9:55 and activity was completed at 9:10. How shall we handle impact of day light savings in such case for reports and audit trails?

2. Do we require Audit trails for each activity. ? E.g. If software is prepared to manage documents. And we have some activities like News and Events on dash board for employees which is not critical step or basic requirement of application.

So do we require audit trail for such activities which are not critical for intended use of software. And if yes, do we require reason for each step?

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Ten GMP Self Inspection or Internal Audit Considerations

Posted as a LinkedIn article on 20190718

Preamble

I am a microbiologist with over 15 years’ experience in the pharmaceutical industry supporting the manufacture of liquids, creams, ointments and tablets. I have a strong interest sterile manufacturing, leading and developing others. Recently I have been working closely with data security. I have an arty streak, an affinity for computers and ride bicycles…a lot.

Introduction

Good Manufacturing Practice in Australia uses recommendations presented in the PIC/s Guide to GMP (PE009-13). The section on Quality Management states, “there is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Pharmaceutical Quality System”. Chapter 9 deals entirely with Self Inspection and lists 3 points – not entirely helpful. Continue reading

What are the guidelines for autoclave re-Validation?

The Question posed on LinkedIn:

Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you

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Question regarding classification of passthroughs and laminar flow hoods

The Question posed on LinkedIn:

Can we provide the grades of pass box and lafs in on critical area with respect to material movement ? For example if a pass box installed between grade c and grade d environment can be designated as grade b? Similarly laf installed in grade c area can be designated as grade c? If yes what woukd be the viable and non viable limits to be applied?

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