Qualified Person
Veronika Lothian is a qualified QP per Article 49 of 2001/83/EC directive since 4th of July 2002.
She was listed on the Manufacturer’s Licence of MSD Cramlington and released solid dosage forms (tablets, capsules and rapid dissolving tablets manufactured by a contract manufacturer).
She has 10 years experience on the medical device field as well hence well suited to release combination product.
She understands the importance and the impact of the QP role on your business and it’s interrelationships with the regulators and the ultimate customer the patient.
She is a fellow of the Royal Society of Chemistry and maintains her knowledge of the regulations and expectations, keeping abreast of changes and developments on the field.
She regularly updates her Continuous Professional Development and holds professional indemnity insurance.
Veronika is able to provide short or long term assistance to small or large orgnanisations who are in need of QP support for day to day product release or back up services but cannot commit to permanent/ full time QP(s).
Services
As a QP she will be able to offer
- Product release activities
- Combination products (medical device + drug combination)
- Solid dosage form experience
- Other dosage forms after familiarisation
- Participation in deviation/ non conformity, customer complaint investigations and review of change controls
- Self inspection audits, supplier and third party audits
- Regulatory compliance checks and license maintenance
- GMP training
- Mentoring and support for trainee QPs