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Compliance Seminars®

Batch Record Review and Investigations

This course concentrates on the practical applications of GMP and FDA compliance requirements, from the batch record review process to final batch disposition.


 

Course description:

It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of discrepancies noted from batch production and testing and the decision making process for the final disposition of the batch (i.e., release, reject or rework).

The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and “how-to” instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA- 483 citations and “real-life” experiences. The knowledge acquired from the lecture is, then, applied to class workshops to enhance the practical skills for conducting batch record reviews, identifying significant discrepancies, conducting the necessary follow-up investigations and making the appropriate decision for batch disposition.

All topics and workshops in this course include examples for sterile and non-sterile products.

Course outline:

  • GMP Requirements for Batch Records
  • Recommendations for Reviewing Batch Records
  • Variance/Deviation/Non-Conformity Systems
  • Compliance Requirements for Follow-up Investigations
  • Evaluation of Investigation Findings
  • Review Examples of Investigation
    • Laboratory out-of-specification test results
    • Dissolution test failure
    • Sterility test failure
    • Labeling and product reconciliation discrepancies
    • Labeling and product mix-ups
  • Preparing the Investigation Report
  • Class Workshop: Variance/Deviation/Non-conformity Classification
    • When to classify and document an “event” as a Deviation/Variance/Non-conformity
  • Class Workshop: Batch Record Review
    • Recognizing batch record discrepancies and GMP compliance deficiencies
    • Identifying the potential causes for the follow-up investigation

Learning objectives:

This course will teach the attendees how to perform a technical review of batch records to detect hidden compliance and quality problems. They will also acquire the skills to conduct the appropriate follow-up investigation and make the final decision or recommendations.

Who should attend:

This course is intended for Production, Quality Assurance and Compliance personnel who are responsible for making batch record entries and performing reviews and compliance investigations. This course is suitable for both entry-level batch record reviewers and compliance personnel, as well as advanced-level personnel, including supervisors and managers.

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

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Course facts

Course no:
5301
Industry:
Pharmaceuticals, Final dosage form

Level:
Intermediate / Advanced
GMP region:
US

Language:
English
Instructor:

Mr. John Y. Lee

Date, location and venue:
No planned sessions .

Time:
2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price (excl. local VAT):
€ 1925 incl. course material (pdf), lunches and refreshments
Note. Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.