Advanced Regulatory Affairs for Medical Devices Training Course
An Introduction to Pharmaceutical Packaging Training Course
15-16 Mar 2021 - London
Also on: 17 Mar 2021
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
An Introduction to the Design and Development of Medical Devices Training Course
14-15 Oct 2020 - Online webinar
Also on: 24 May 2021
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
An Introduction to the Medical Device Regulation Training Course
11-13 Nov 2020 - Online webinar
Also on: 12 May 2021
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
Biological Evaluation of Medical Devices Training Course
18-19 May 2021 - London
Also on: 23 Nov 2021
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course
1-2 Dec 2020 - Online webinar
Also on: 3 Dec 2020
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Cyber Security for Medical Devices Training Course
Data Integrity and Document Management Training Course
4 Mar 2021 - London
Also on: 5 Mar 2021
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Development of Combination Products: Critical Interactions Training Course
17-18 Nov 2020 - Online webinar
Also on: 5 May 2021
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
24-25 Sep 2020 - Online webinar
Also on: 26 Apr 2021
Practical guidance on borderline Issues and combination products
Dry Powder Inhalers Training Course
EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course
26-27 Jan 2021 - Online webinar
Also on: 28 Jan 2021
This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.
Effective Technical Writing & Editing Training Course
Effective Technology Transfer Training Course
FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course
22-23 Mar 2021 - London
Also on: 24 Mar 2021
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
How to Write Effective SOPs (Standard Operating Procedures) Training Course
3 Dec 2020 - Online webinar
Also on: 28 Jun 2021
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course
30 Sep-1 Oct 2020 - Online webinar
Also on: 23 Feb 2021
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Improving Processes and CAPA (Corrective and Preventative Action) Training Course
4 Dec 2020 - Online webinar
Also on: 29 Jun 2021
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Injectable Drug Delivery Training Course
Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course
3-4 Nov 2020 - Online webinar
Also on: 11 May 2021
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course
Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course
7-8 Oct 2020 - Online webinar
Also on: 6 Oct 2021
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Medical Device Regulations in the Middle East and North Africa Training Course
30 Jun-1 Jul 2021 - Online webinar
Also on: 7 Jul 2021
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
*Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen*
Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course
17-19 Nov 2020 - Online webinar
Also on: 28 Apr 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Studies: Clinical Evidence Training Course
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course
23-24 Feb 2021 - Online webinar
Also on: 25 Feb 2021
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Medical Writing for Medical Devices Training Course
Metered Dose Inhaler (MDI) Technology Training Course
Nasal Drug Delivery Training Course
New Medical Device Regulation Training Course
15-16 Mar 2021 - London
Also on: 17 Mar 2021
Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
Pharmaceutical Packaging, Labelling and Artwork Origination Training Course
27-28 Oct 2021 - London
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Pre-Filled Syringes: End-to-End Processing Training Course
23-24 Mar 2021 - Online webinar
Also on: 25 Mar 2021
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course
8-9 Mar 2021 - London
Also on: 10 Mar 2021
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
The Medical Device Summer School - From Concept to CE Marking Training Course
5-9 Jul 2021 - London
*A practical five-day course with interactive workshops - now in its 17th successful year!*
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.