Steve

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regulations-custom-made-medical-devices

Custom-Made Medical Devices | Changes – February 25, 2021

Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf …

Staff Promotion

Eleanor Redding – Senior Consultant

PharmOut is delighted to announce that Eleanor Redding has been promoted to the role of Senior Consultant.

Eleanor has over 20 years’ experience in the pharmaceutical industry and specialises in quality management systems, compliance and technical document writing. She has …

PharmOut Compliance, Validation, Engineering

Senior GMP and Validation Consultant

Congratulations Colin Byrne
PharmOut is delighted to announce that Colin Byrne has been promoted to the role of Senior Consultant.

Colin has over 12 years of experience in the pharmaceutical industry, including more than 4 with PharmOut. He has gathered a …

Sue MacLeman MTPConnect

Australian-first Manufacturing and Hands-on Training Facility

Australian-first manufacturing and hands on training facility to produce medical products for early stage human clinical trials receives funding from MTPConnect’s Project Fund Program
PharmOut is proud to partner with these prestigious Australian organisations and would like to congratulate MTPConnect …

Clean Room Designers

Clean Room Designers

PharmOut is a multi-disciplinary team of expert pharmaceutical architects and engineers, we are Australia’s leading pharmaceutical clean room designers, working for cosmetics manufacturers, non sterile and sterile pharmaceutical manufacturers around the world to provide Architecture and Engineering services.

Manufacturers, often …

Large Indoor Marijuana Commercial Growing Operation With Fans, Greenhouse, Equipment For Growing High Quality Herb. Cannabis Field Growing For Legal Recreational Use in Washington State

United in Compassion Medicinal Cannabis Symposium 2017

As the evidence that Medicinal Cannabis is an effective medical treatment for some conditions, the timing of the third Medicinal Cannabis Symposium is critically important for Australia as we experience the initial growing pains, frustration, controversy, which could be addressed …

pics tablets

PIC/S Version 13 is here, are you ready?

For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to …

3D-printer

Custom Medical Devices TGA / ISO 13485:2016 Certification

Do I really need ISO 13485:2016 certification?
There has been rapid growth in the area of custom-made medical devices, made for single known, patients and this has led to the authorities issuing additional guidance. Innovative companies around the world are producing …

Ashley Isbel Lead Consultant

Bryan Wright, ex-MHRA Inspector joins PharmOut

On the 1st April 2016, he joined PharmOut as an Executive Consultant.

Bryan brings extensive European regulatory compliance experience to PharmOut having spent most of his 22 years as GMP Inspector, later as a GMP expert inspector, the last 5 …