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Best Compliance Practices at the GMP Testing Laboratory

Jun 28 - Jun 29, 2018
Berlin, Germany

This course provides detailed understanding regarding the implementation of respective cGMP requirements in a state-of the- art quality control laboratory in a pharmaceutical company.

  • Education
  • Europe

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Overview

This course provides detailed understanding regarding the implementation of respective cGMP requirements in a state-of the- art quality control laboratory in a pharmaceutical company. The course does not just provide an overview about the most important cGMP regulations (OOS management, sample management, method validation, training, documentation, data management). In extensive workshops those regulations are further explained and extensively discussed within the group and solutions for the implementation are developed. Those results are further discussed with the trainers and with all attendees. This approach will not only provide the respective knowledge but also the ability to implement those solutions in the laboratory of the attendees.

Who Should Attend

The course should be attended by operators and supervisors in quality control laboratories of the pharmaceutical industry which are faced with the challenge to implement those, sometimes complex cGMP regulations into their daily business in an efficient and effective manner.

  • Laboratory personal
  • Head of quality control laboratories
  • Supervisors
  • Quality Assurance personal focusing on quality control topics, for example quality-on-the-floor personal

Learning Objectives

  • Understanding how the most important cGMP requirements can be implemented in the quality control laboratory
  • Development of approaches regarding the implementation of cGMP compliance within the quality control laboratory considering German and international regulations
  • Competence regarding the implementation of data integrity compliance in the quality control laboratory, for example “audit trail review”.
  • Self-contained management of OOS-results
  • Development of sampling protocols using statistical tools
  • Implementation of training programs in quality control laboratories

Faculty

Dirk Feldmann, PhD, Head of Quality Operations, QP, Bausch & Lomb, Berlin
Dirk Feldmann studied Pharmacy at the FU Berlin and finished his PhD thesis in Food Chemistry at the TU Berlin. In 1996 he became the laboratory head of several analytical laboratories of the German military forces in Berlin. Since 2006, he has held various positions at Bausch & Lomb, Berlin (Head of laboratory for bulk, finished goods and stability control and deputy head of QC, Head of Quality Assurance, Qualified Person, Head of Manufacturing). Currently Dirk Feldmann holds the position of Head of Quality Operations/Batch Release and QP at Bausch & Lomb, Berlin. Furthermore, between 2010 and 2012 he held the position of a pharmacist at Saint Luke Foundation / Kilimanjaro School of Pharmacy in Moshi, Tanzania as part of his work in an international development aid project.


Klaus von Jan, PhD, CRS Compliance & Regulatory Services
After his studies of chemistry at the TU Stuttgart and his PhD in Organic Chemistry about the synthesis and characterization of the structure of Oligonucleotides, Klaus von Jan joined Millipore BioSyntech GmbH, Hamburg, as Head of Quality Control and Quality Assurance in 1988. In 1995 he joined Chiron Vaccines Germany in Marburg as Director Quality Assurance Bulk Manufacturing Germany. Since 2006, Klaus von Jan is an independent consultant in the pharmaceutical industry focusing on aseptic manufacturing, vaccines and biologics, quality control, computer system validation, data management, FDA inspections and interims management. He has been the co-founder of Compliance Systems GmbH in 2006 as well as co-founder and co-owner of the Swiss-based pmc-support GmbH.

Agenda

  • Thursday, 28 June 2018

    9:00
    Welcome & Introduction


    9:45
    cGMP-Requirements in the Quality Control Laboratory - A Short Overview

    • OOS-management, aborted tests
    • Method Validation / Method Verification
    • Sample Management
    • Sampling
    • Data Management
    • Documentation
    • Training

    10:45
    Coffee Break

    11:15
    Case Study 1 / Workshop: OOS-Management, Practical Example

    • Case explanation
    • Expectation of the teamwork
    • Presentation of results
    • Best Practice discussion

    12:30
    Lunch Break

    13:30
    The QP in the Quality Control Laboratory

    • Typical issues / failures in the daily business
    • Failure during sampling
    • Development of sampling protocols
    • Statistical tools for determination of sample size

    15:00
    Coffee Break

    15:30
    Case Study 2 / Workshop:

    • Development of a sampling protocol and determination of the sample size based on the presented methods
    • Presentation of results and Best Practice discussion

    17:00

    End of Day 1

    Friday, 29 June 2018

    9:00
    Recap Day 1, Open Questions


    9:30
    Introduction to Data Management

    • 21 CFR Part 11, Annex 11
    • Expectations of authorities (MHRA, FDA)
    • Data integrity
    • Batch related audit trail review
    • Documentation and data security

    10:45
    Coffee Break

    11:30
    Case Study 3 / Workshop

    • Management of an FDA 483 observation regarding data integrity
    • Implementation and documentation of a batch related audit trail review
    • Presentation of results and Best Practice discussion

    12:30
    Lunch Break

    13:30
    Case Study 4 / Workshop

    • Method Validation / Method Specification
    • Development of an activity protocol for the relocation of a sterility laboratory
    • Presentation of results and Best Practice discussion

    14:30
    Coffee Break

    15:00
    Case Study 5 / Workshop: Development of a Training Program for a Quality Control Laboratory

    • How can you organize a wide range of trainings in an efficient and effective manner
    • Success controls
    • Development of a training program

    16:00
    Summary, Open Questions, Feedback


    16:30
    End of Course

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

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Berlin Mariott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany

How to Get Here

By Air

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By Car

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Other Options

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Directions

Registration Fees

Regular Price

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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