Seminar on Exporting Medicine to PIC/s Countries, WHO Qualification & cGMP Regulatory Requirements March 6th, 2018 in Lahore & March 7th, 2018 in Karachi

Time: 9:00am - 5:00pm Download PDF
Venue: Lahore-Karachi Reg Form
Info: ceeinfo@iba.edu.pk  
Contact: Tel: (0213) 8104700 (Ext:1804, 1807, 1809)  
  • Introduction

    Pharmaceutical Consultancy Services (PCS), the Center for Executive Education IBA/CEE and Operational Excellence Consulting (OEC) organize the one-day seminar: Exporting Medicine from Pakistan to PIC/s Countries and WHO Qualifications, cGMP Regulatory Requirements.

    As the Drug Regulatory Authority of Pakistan (DRAP) is moving to get PIC/s pre-accession, it should be easier for Pakistani companies to export their products to the world's largest markets. This seminar will benefit companies seeking to export to the United States, Europe or the countries covered by PIC/s. Before a Pakistani company is allowed to, export to any of the markets above it will be subject to regulatory inspection against the Good Manufacturing Practices (GMP) guidelines.

    Every organization has their own view on these practices and has a distinct inspection approach. Understanding the practical implications of these differences can be extremely difficult.

    During the seminar industry, experts will elaborate on the requirements and expectations of PIC/s & WHO inspectorates. Practical examples will be provided as well as theoretical guidance to help your company take the first steps toward international regulatory compliance.

  • PCS Experience - Notable Projects
    • Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA Approved.
    • China Vaccine Project, Design Qualification, QA support and training for three vaccine and biotech manufacturing plants in China. WHO Qualified.
    • Developing Countries and Vaccine Manufacturers Network (DCVMN) helped organize and train at a number of training courses to promote the development of local pharmaceutical industries in China and Brazil.
    • Selecting suitable suppliers of API's, processors of intermediates and packagers of finished products for an Australian generics organizations launching a new product. These audits are being performed in Spain, Australia, Bangladesh and Canada. All inspections are conducted against the EudraLex Volume 4.
    • GAP-assessment for a Chinese biotechnology company in a BSL-3 facility including CAPA recommendations.
    • WHO Pre-Qualification assessment for a Chinese manufacturer of pharmaceuticals including CAPA recommendations and assisting in the subsequent upgrade efforts.
    • Nine-day auditor certification training programs provided to one of the largest pharmaceutical organizations in India, in three subsequent sessions. The auditors were part of the corporate auditor team, performing supplier inspections.
    • The supply of an Interim Head Corporate Quality Assurance to two medium-sized pharmaceutical production organizations in India. Additionally, to guide these organizations through WHO-inspections and to assess their QMS through a 4-person quarterly audit. WHO Qualified.
    • Design Qualification of a Biotech Facility in South Korea.
    • Great number of audits conducted against FDA, WHO and EMA regulatory requirements over the past few years.
    Vision for Pakistan's Pharmaceutical Industry

    We are expecting the Pakistan pharmaceutical industry to become a key player in the international field of medicine. Following the PIC/s accession it will be easier for Pakistani organizations to export their medicine. We are committed to aiding the Pakistani organizations in this goal.

    PCS and OEC will continue providing seminars on general GMP topics to help further advance your level of compliance. In addition PCS and OEC can provide consultancy and audits to assist you in becoming compliant with organizations such as the; U.S. FDA, European Medicines Agency (EMA), WHO and PIC/s.

  • Who should attend?

    This seminar will be extremely beneficial for representatives of Pakistani companies who are seeking to export their products across borders. These companies may include producers of Finished Products and Active Pharmaceutical Ingredients (API) or Excipients. Organizations who support the Pakistani pharmaceutical industry may also find this seminar useful for better understanding the increased requirements that will be placed upon them by the pharmaceutical industry.

  • Learning Outcomes
    • A better understanding of the international regulatory requirements,
    • Useful pointers for upgrading your Quality Management System (QMS) to global GMP requirements,
    • Insight into how regulatory authorities will inspect your organization and against which criteria,
    • Knowing which regulations apply to your company and where to find them,
    • The latest trends in the pharmaceutical industry such as Quality Culture, Data Integrity, and Serialization.
  • Faculty
    Eng. Mr. Jaap Koster (CEO, Senior Consultant)

    Jaap Koster has worked in the United States as Vice-President Corporate Quality Assurance for five years in the preparation of a product introduction of a novel vaccine, and during his career worked for and with blue-chip USA pharmaceutical companies.

    Jaap has 32 years of experience, based in various positions (including auditing and training) within (pharmaceutical and food) operations in USA, Asia and Europe in diverse processes: bulk chemicals, (aseptic) biologics and packaging- performed many Pharmaceutical companies audit around the globe as per FDA, WHO, MHRA and PIC/s guidelines.and also third party audits of Pharma companies. Projects involved Auditing, Quality (Systems), Validation, Operations, Engineering, Project Management (including BSL-3 and aseptic Cleanrooms), Logistics and cultural turn-a rounds.

    He has helped diverse companies for recovery after disapproval by regulatory agencies.

    Jaap is performing training-programs worldwide, working with the DCVMN, UNIDO and WHO on inspections and global training programs.

    Julian Koster (Consultant)

    Over 11 years of experience with the ins- and outs of the pharmaceutical and business industry. This combination allows Julian to assess and subsequently change practical problems without hesitation. An analytical mindset has allowed him to explore Computerized Systems Validation (CSV) from the EU GMP and GAMP 5 perspective and implement this knowledge in the pharmaceutical industry

    Julian was involved in the GDP audits in Netherlands, as well as co-audit of GMP audit in India. He has done validation of computerized system as well as the development of a CSV – Quality Management System.

    Julian is trained for cGMP practices for Mid-level Management, determining Critical factors in Sterile (Aseptic ) Production as well as Auditing and Suppliers Qualifications.

  • Fees
    PKR 35,000/participant:

    Inclusive of Course material, IBA Seminar Certificate, Lunch, Refreshments & Business networking

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