Regulatory Inspection Ready? FDA MHRA EMA
Regulatory Inspection Ready? FDA MHRA EMA
Regulatory Inspection Ready? FDA MHRA EMA
Whatever your FDA inspection or MHRA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.
Whatever your FDA inspection or MHRA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.
Whatever your FDA inspection or MHRA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.
Are You Ready For An FDA, MHRA Or EMA Inspection?
For Pharmaceutical and Medical Device Manufacturing, Zener Engineering Services Ltd (ZES)
have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond.
Supported
Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise. ZES can provide support with the following areas of potential inspection observations, which have been a focus in recent inspections:
- Personnel
- Data Integrity
- Documentation
- Quality Control
- Quality Systems
- Sterility Assurance
- Production Systems
- Complaints and Recall
- Computerised Systems
- Qualification / Validation
- Premises and Equipment
- Good Engineering Practice
- Inspection Preparation and Training
Are You Ready For An FDA, MHRA Or EMA Inspection?
For Pharmaceutical and Medical Device Manufacturing, Zener Engineering Services Ltd (ZES)
have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond.
Supported
Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise. ZES can provide support with the following areas of potential inspection observations, which have been a focus in recent inspections:
- Personnel
- Data Integrity
- Documentation
- Quality Control
- Quality Systems
- Sterility Assurance
- Production Systems
- Complaints and Recall
- Computerised Systems
- Qualification / Validation
- Premises and Equipment
- Good Engineering Practice
- Inspection Preparation and Training
Are You Ready For An Inspection?
FDA, MHRA Or EMA?
For Pharmaceutical and Medical Device Manufacturing, Zener Engineering Services Ltd (ZES) have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond. Supported
Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
ZES can provide support with the following areas of potential inspection observations, which have been a focus in recent inspections:
- Quality Systems
- Sterility Assurance
- Production Systems
- Complaints and Recall
- Computerised Systems
- Qualification / Validation
- Premises and Equipment
- Personnel
- Data Integrity
- Documentation
- Quality Control
- Good Engineering Practice
- Inspection Preparation and Training
FDA inspection or MHRA inspection concerns?
Supported by ZES, GxP clients achieve successful outcomes. ZES have worked with former FDA inspectors.
"ZES are superb in delivering
a great service."
Peter West
Head of Quality Affairs at ECLEVAR
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
FDA inspection or MHRA inspection concerns? Supported by ZES, GxP clients achieve successful outcomes. ZES have worked with former FDA inspectors.
ZES Experience Of Regulatory Inspections
ZES have worked closely with inspectors to help ensure inspection success. Whatever your FDA, MHRA or EMA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.
The ZES experienced FDA, MHRA or EMA inspection trainer can deliver bespoke Inspection Readiness Training, to help achieve a successful inspection outcome.
ZES Experience Of Regulatory Inspections
ZES have worked closely with inspectors to help ensure inspection success. Whatever your FDA, MHRA or EMA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.
The ZES experienced FDA, MHRA or EMA inspection trainer can deliver bespoke Inspection Readiness Training, to help achieve a successful inspection outcome.
Need A Helping Hand With Inspection Training?
Our experienced FDA, MHRA or EMA inspection trainer will deliver a valuable training course covering subject matters such as the following:
- Logistics
- Case Studies
- SME Training
- Dos and Don'ts
- Inspector Facts
- Question Styles
- Common Pitfalls
- Practice Scenarios
- Inspection Preparation
- Back Room Operations
Need A Helping Hand With Inspection Training?
Our experienced FDA, MHRA or EMA inspection trainer will deliver a valuable training course covering subject matters such as the following:
- Logistics
- Case Studies
- SME Training
- Dos and Don'ts
- Inspector Facts
- Question Styles
- Common Pitfalls
- Practice Scenarios
- Inspection Preparation
- Back Room Operations
Need A Helping Hand With Inspection Training?
Our experienced FDA, MHRA or EMA inspection trainer will deliver a valuable training course covering subject matters such as the following:
- Logistics
- Case Studies
- SME Training
- Dos and Don'ts
- Inspector Facts
- Question Styles
- Common Pitfalls
- Practice Scenarios
- Inspection Preparation
- Back Room Operations
Don’t just take our word for it...
Pharma Facility: Site Validation Lead
"David of Zener Engineering Services Ltd was working as a validation lead when I was acting as a consultant QP for a client.
I found David to be very knowledgeable in this field and I would recommend him."
Robert Smith Qualified Person
Smiro Qualitas Ltd
Your Dedicated ZES Validation Consultant
ZES give the customer the assurance
and peace of mind of a single point of contact,
with full accountability.
A dedicated ZES Validation Consultant is ready
to help you with your requirements.
Your Dedicated
ZES
Validation Consultant
ZES give the customer
the assurance and peace of mind
of a single point of contact,
with full accountability.
A dedicated
ZES Validation Consultant
is ready to help you with your requirements.
Your Dedicated
ZES Validation Consultant
ZES give the customer
the assurance and peace of mind
of a single point of contact,
with full accountability.
A dedicated
ZES Validation Consultant
is ready to help you with your requirements.
Registered Office:
Rutherford House,
Warrington Road,
Birchwood,
Warrington, WA3 6ZH
United Kingdom.
Regional Office:
NETPark Plexus 2,
Thomas Wright Way,
Sedgefield, TS21 3FD
United Kingdom.
Contact Us:
Tel: (+44) 0843 5236 320 (Industry)
Tel: (+44) 0843 5236 325 (NHS)
Calls Cost 7p per min
Registered Office:
Rutherford House,
Warrington Road,
Birchwood,
Warrington,
England, WA3 6ZH
United Kingdom.
Regional Office:
NETPark Plexus 2,
Thomas Wright Way, Sedgefield, TS21 3FD
United Kingdom.
Contact Us
Tel: (+44) 0843 5236 320 (Industry)
Tel: (+44) 0843 5236 325 (NHS)
Calls Cost 7p per min
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