GMP, GAMP® & Validation Training > Validation Training > Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training


Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training

Course Title:Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
Course Delivery:

The Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training Course can be delivered in a hotel, one of our offices, or your premises. The course content can be tailored to meet your requirements. Request a quote for an onsite course.

Course Duration:1 day
Course Overview:

The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997.  The Interpreting the Regulation 21 CFR Part 11 and revised EU Annex 11 (1 Day) Training Course, seeks to demystify misconceptions and beliefs on what it means for companies.

The course also provides a review and comparison of Part 11 with Annex 11 and related EU GMP Volume 4 Chapter 4 on Documentation.

Regulated life science companies rely on the integrity of their data to ensure product quality. With increasing use of computerised systems in GMP operations regulatory authorities need to be assured that companies can manage the challenges that face them in understanding the complexities surrounding this subject and be confident that implemented strategies are effective.

So if you want to understand 21 CFR Part 11, what has been revised in the EU GMP Annex 11 and Chapter 4, and examine the GAMP®’s interpretation of the guidance, and the subject of data integrity then why not attend our course?

Course Content:
  • Understand the regulation 21 CFR Part 11
    • What the requirements are
    • Why is the regulation necessary?
    • The difference between guidance and regulation
  • Identify key terminology used in the regulation
    • Terms and definitions
  • Lifecycle of a document
    • Electronic
    • Hard copy
    • Records
  • What is in and out of scope?
    • Validation requirements for computer systems
    • Predicate regulations - what are they, where to look and why?
    • A focus on risk to records and the 'Hybrid' approach
    • Links to validation
      • Validation requirements for computer systems
    • Training
      • Requirements
      • Qualifications and experience
    • Management of systems
      • For open and closed systems
      • Physical and logical controls
    • Signatures
      • Signature/record linking
      • Their uniqueness
      • Biometrics
    • Controls
      • Password ageing
      • Procedures
      • Management responsibilities
    • Understand FDA Part 11 Guidance for Industry
      • Latest thinking and guidance
      • Why the FDA is now assessing whether companies are using its revised guidance
    • Recall problems encountered by companies applying the rule
      • Potential problem areas
      • Case studies
      • Differing scenarios/FDA warning letter reviews
      • Comparison between how the FDA used to audit and report compliance issues and how it is now
    • Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures
      • Review includes:
        • Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation
        • Updates from previous revision of Annex 11
        • Cross reference to Part 11
    • Describe the GAMP® approach to 21 CFR Part 11 compliance
      • Links with GAMP® and risk assessment
      • Review examples from the guide
      • Use GAMP® risk assessment to assess a potential real scenario
    • Explore the subject of data integrity and understand the reasons for the current regulatory focus including:
      • European and FDA regulatory guidance
      • Challenges to Data Integrity and effective strategies
      • Data Integrity control measures

    ISPE owns the GAMP® trademark http://www.ispe.org/



    Open Course Dates:
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    11 July 2019, Exeter, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    18 July 2019, Near Manchester Airport, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    15 August 2019, Near Manchester Airport, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    5 September 2019 - 16 May 2019, Near Manchester Airport, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    12 September 2019, Cork, £597+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    12 September 2019, Glasgow, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    19 September 2019, Manchester, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    17 October 2019, Near Manchester Airport, £546+VAT per learner.
    Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training
    7 November 2019, Near Manchester Airport, £546+VAT per learner.
     
     

    GROUP BOOKING DISCOUNT - Book more than one place on an open course and receive the following discounts:

    • 10% discount on second place
    • 20% discount on third place
    • 25% discount on fourth place

    Group booking discounts cannot be used in conjunction with any other offer.

    Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.

    Onsite Courses:

    This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

    ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

    Testimonials:

    “Very interesting.”
    AbbVie Ireland NL B.V.

    “Excellent content and delivery.”
    AbbVie Ireland NL B.V.

    “Great course and experienced trainer.”
    AbbVie Ireland NL B.V.

    “Structured, informative and applicable.”
    AbbVie Ireland NL B.V.

    “The course gives a good history and understanding.”
    ITCM

    ITS Tutor's Experience:

    ITS’ Regulatory Compliance Services’ Manager, Elizabeth Vaughan, has developed extensive knowledge of this specialist area from over 30 years’ industry experience working with Sanofi, Bristol Myers Squibb, Diomed Developments and Vifor Pharma UK. Elizabeth has worked in quality roles within the laboratory and pharmaceutical industry, and gained extensive experience in global quality systems and regulatory affairs, as well as ISO 13485, ISO 9001 and cGMP compliance. Throughout her career, she has been responsible for sharing her knowledge through the design and delivery of a range of training courses for production personnel including Good Manufacturing Practice, Change Control, Deviation Management, Electronic Record Compliance, Validation and Management of API Suppliers/Manufacturers. Elizabeth also has extensive experience in providing quality and GMP training to improve the performance of site quality managers.

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    Further Information:
    Request more information on this training course.



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    For further information, please contact
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    email enquiries@its-ltd.co.uk