Auditing - Active Pharmaceutical Ingredients

RSSL Training

Training

In Reading

£ 620 + VAT

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Description

  • Type

    Training

  • Level

    Beginner

  • Location

    Reading

  • Duration

    1 Day

Facilities

Location

Start date

Reading (Berkshire)
See map
The Science & Technology Centre, Earley Gate, Whiteknights Road, RB6 6BZ

Start date

On request

About this course

This course will provide the basic knowledge base and skills to enable effective auditing and reporting on audits of suppliers of active pharmaceutical ingredients (APIs)

This course is intended for people who have had some auditor training and experience in conducting audits

To make a booking or discuss any aspect of your training courses, contact our customer services team:
t: +44(0) 118 918 4076
e: enquiries@rssl.com

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Reviews

Subjects

  • Enable effective auditing
  • Reporting on audits of suppliers
  • Basic manufacturing techniques

Teachers and trainers (1)

Steve Porter

Steve Porter

RSSL Tutor

Course programme

  • The course will be assessed and certified by RSSL against the standards of ICH Q7. By the end of the course you will be able to:
    • Understand the regulatory requirements for conducting API audits
    • Provide background information and scope for a supplier audit
    • Create a structured approach in preparation for an API audit
    • Conduct an API audit
    • Create a check list of questions to ask
    • Identify non conformities against ICH Q7 and regulatory expectations
    • Identify product specific requirements
    • Have knowledge of the basic manufacturing techniques and equipment used
    • Understand the requirements for Good Control Laboratory Practices (GCLP)
    • Produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
    • Produce a report that demonstrates the continuing suitability and certification of the API(s) in question
    • Know how to obtain auditee cooperation and acceptance of findings

Additional information

https://www.rssl.com/Our-Expertise/Training/Pharmaceutical/Auditing-Active-Pharmaceutical-Ingredients

See related categories

Auditing - Active Pharmaceutical Ingredients

£ 620 + VAT

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