GMP & GDP
What's the medical device industry's requirements?
ISO 13485 & 21 CFR part 820
What pencil colors shall we use for entering the data?
Pencils are not allowed!
Which leader worked in 3 countries?
Arun Giddu (India, UK and USA)
Who is The Food and Drug Administration (FDA)?
Government Entity that oversees drug manufacturers
Largest Value Stream
VS2
In the medical device industry, what's the 'treasure map' guiding you to comply with quality standards and regulations?
Standard Operating Procedures (SOPs)
List three examples of uncontrolled documents in a medical device company.
Draft versions of procedures, outdated work instructions, unofficial memos
Which Senior Leader hunts?
Penny Mathias
List 3 tips for successful interactions with an auditor?
Be professional
Answer questions briefly and accurately
Be honest, respectful, confident, and credible
Reference written policies, procedures, and manuals
What is the slogan of Thermo Fisher Scientific?
Making the World Healthier, Cleaner and Safer!
How to correct an error in a document?
Draw a line on error, type correct data, initial& date, Add comment & initial & Date
Name the document that outlines the structure and processes of a QMS.
Quality Manual
Which senior leader retired from the Military?
Jim Evenson
List 3 things you should NOT do during the audit?
Attempt to be flip or funny with the auditor
Have irresponsible conversations nearby
Answer unasked questions
Distract the inspector
What do SDG & CDR stand for?
Specialty Diagnostics Group (SDG)
Clinical Diagnostics Reagent (CDR)
Why is it important to follow SOPs exactly as written?
To ensure consistency, compliance, and quality
What are the consequences of non-compliance with GMP or GDP?
Product recalls, regulatory penalties, loss of reputation, and legal action
Which senior leader knows 6 languages?
Asiya Imam (English, German, French, Persian, Arabic, Urdu)
What's the "secret sauce" for achieving audit readiness?
Strong documentation and adherence to procedures.
What was the original name of Thermo Fisher Scientific before a merger in 2006?
Thermo Electron Corporation
What is a critical equipment attribute to verify before use?
Before using a piece of equipment you need to verify that calibration is within this dating period.
What is the primary objective of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in the pharmaceutical industry?
Ensure product quality, safety, and efficacy.
Which leader builds his/her furniture?
James Pope
What are the key documents typically requested during a regulatory audit in the medical device industry?
Device master record (DMR), device history record (DHR), complaint files, CAPA documentation, and supplier records.
Where are the locations of all 5 SDG sites?
USA (Middletown, Fremont)
Hennigsdorf, Germany
Nimes, France
Vantaa, Finland