2010 Critical Thinker Series

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1 Malaysian Organisation of Pharmaceutical Industries (MOPI) & PharmEng Technology Presents cgmp Case Studies a T rra ini ing i P rrog rram ffo rr cgmp P rro ffe ss ss ionai l ss 2010 Critical Thinker Series Objective Designed according to the Malaysian industry s recent developments, this program will: Emphasize on case studies and problem solving, and Broaden discussions on traditional facilities such chemically and herbal facilities that make up the core of the Malaysian industry The objective is to promote a culture of problem-solving, reasoning, and critical thinking that is immediately relevant to the current industrial atmosphere in Malaysia, while giving students gradual exposure to advanced products and facilities. Who should attend & What participants will benefit from The case studies are designed to target intermediate-level (3 to 10 years) industry professionals in the areas of management, QA, QC, engineering, validation, regulatory affairs, compliance, and production operations. Participating companies are encouraged to send multi-disciplinary delegates for maximum exposure. Senior-level industry professionals are also welcomed and may serve as team leads in group discussions. Instructors Instructors come from today s industry leaders worldwide. We recognize that Malaysia is unique, and therefore we select instructors not only based on their leading technical and teaching experiences, but also based on the audiences technical and cultural background in order to build the best studentinstructor interaction for the Malaysian environment. Certificates Certificates endorsed by the National Pharmaceutical Control Bureau, Ministry of Health, Malaysia will be awarded to participants upon successful completion of the training module. Training Grant is available under HRDF SBL Scheme Presented by Organised and Endorsed by: Malaysian Organisation of Pharmaceutical Industries Jointly Organized by National Pharmaceutical Control Bureau Ministry of Health Malaysia

2 2010 Case Study Outline & Schedule Case Study Title Dates* Instructors* Case Study 1: Good Distribution Practices An overview of Good Distribution Practice (GDP) that is a part of QA which ensures that products are consistently stored, transported and handled under suitable condition. For supply-chain professionals. 05, 06 April 2010 Kevin Scannell, Principal, Ea Consulting, Canada Case Study 2: Audits, Findings, Warnings, and Resolutions Examples of warning letters of various degrees of severity and areas of violations. Participants will have a chance to discuss the regulations, rationale, and impact behind these warning letters. For Managers and QA professionals. 07, 08 June 2010 Fenton Fong, Senior Consultant, PharmEng Case Study 3: Analytical Methods, Transfers, Validations Examples of analytical methods will be shown and discussed. Participants will have a chance to discuss the differences between these types of tests and how to design an appropriate validation program. For Chemists, Microbiologists, and QA professionals. 12, 13 July 2010 Peter Doherty, Senior Consultant, PharmEng Case Study 4: Facility Upgrade -- cgmp Life Cycle Scenarios involved in upgrading an aging facility or production line are presented and discussed. Participants will discuss what are the problems that can arise when retrofitting onto an outdated facility and how to ensure compliance. For Project Managers, Engineers, and QA professionals. 02, 03 Aug 2010 Ben Lee, Director of Operations, PharmEng Case Study 5: Fill & Finish Facilities and Practices Discuss what is involved in the design, build, and operations of a fill & finish facility. For Project Managers, Engineers, and QA professionals. 04, 05 October 2010 Attila Ari, Director of Operations, PharmEng Technology (USA), USA * Dates and Instructors are subject to change depending on attendance feedbacks and instructor availability. In case of a change, updated dates and instructor profile will be advised to the organizer and the attendees prior to the start of each course. Venue: Eastin Hotel / Boulevard Hotel (to be announced) Details: Detailed course descriptions are available for each course upon enquiry. Registration, Fees, and Contacts: See Next Page. Special Requests: We welcome requests for special topics or on-site training. Please feel free to forward your enquiries to us.

3 Registration 2010 Critical Thinker Series cgmp Case Studies Select a Course: Case Study 1: Good Distribution Practices Case Study 3: Laboratories, Analytical Methods, Transfers Case Study 5: Fill & Finish Facilities and Practices Case Study 2: Audits, Findings, Warnings, and Resolutions Case Study 4: Facility Upgrade -- Validation Life Cycle Delegate Name 1 Delegate Name 2 Delegate Name 3 Delegate Name 4 Registration Contact Tel Fax Full Company Name and Billing Address Fee per participant per course: (The fee includes course materials, lunch and refreshments) Book 30 days before Save Book days before MOPI Member RM RM RM 2000 Non-MOPI Member RM RM RM 2200 Foreign Participant USD USD USD 850 Additional group discount of 4 or more delegates per company: 10% off per delegate Save Book within 13-7 days before Payment Method Cheque No. All payments to be made payable to Malaysian Organisation of Pharmaceutical Industries. Payment is required with registration. Registration will be treated as confirmed only upon receipt of payment in full. Walk-in participants will only be admitted on the basis of space availability at the course and with immediate full payment by company cheque in favour of the Malaysian Organisation of Pharmaceutical Industries. Important Note It may be necessary for reasons beyond the control of the organizer to alter the content and timing of the programme or the identity of the speakers. In the unfortunate event that a module is cancelled MOPI is not liable for any costs incurred by delegates in relation to their attendance. BOOK YOUR SEAT NOW! GET EARLY BIRD DISCOUNT!!! For further enquiries, please contact: MOPI (Mr. Mike) 1st Floor, Wisma Yan, No 17 & 19, Jalan Selangor, Petaling Jaya, Selangor, Malaysia Tel: , Fax: and CANCELLATIONS AND REPLACEMENTS A full refund less 10% administrative charge will be made for cancellation received in writing 14 days before commencement of each module. The full module fee remain payable for cancellation received less than 14 days prior to the commencement of each module. Substitutions are welcome at no extra charge. Regrettably, no refund can be made for cancellations received less than 7 working days prior to the commencement of each module. However a complete set of documentation will be sent to you. Training Grant is available under HRDF SBL Scheme

4 PharmEng International Inc. ( PII ) provides professional development and certification training programs throughout North America and Asia. We deliver over 35 courses to the pharmaceutical, biotechnology, nutraceutical and medical devices industries in the areas of: Best instructor and best coverage of this subject that I ve experienced yet. Great session so glad I came. IMRIS Inc. cgmps Validation Engineering Project Management Medical Devices Quality Compliance Quality Assurance Regulatory Affairs Manufacturing good course, especially the case studies. Genesys Venture Inc. It was a nice change that the instructor had personal experience that I could relate to. Medicure Inc. Why PharmEng Professional Training? Unique curriculum that covers key areas critical to the success of the industry, through courses that integrate theory and practice. Advisory committee that includes members from industry, academia and government, ensuring that important regulatory and industry issues are addressed. Custom courses that cover both general and basic know-how as well as current challenges, issues and new developments in the industry. Instructors that have been selected among industry leaders and subject experts who will provide challenging course work and valuable hands-on experience. PII delivers courses to two distinct groups: 1. Corporate Training: Experienced industry professionals who require current best practices in order to keep up-to-date with industry standards, Good Manufacturing Practices (GMP s) and regulations. 2. Career Training: Next generation individuals seeking careers in the industry who need practical skills and know-how for the pharmaceutical and biotechnology workforce. For those individuals requiring one day professional development programs, courses are available through any of the PII offices located throughout North America with access to course listings, course availability and registration through the PII website Certification Programs For career training and certification, PII offers programs through national and internationally-recognized universities delivering certificate programs such as: 1. The Biopharmaceutical Technology Certificate Program for the University of Waterloo and the National Tsing Hua University College of Life Science in Taiwan 2. The Biotechnology and Pharmaceutical Technology Program for Cape Breton University Instructors and Course Materials All instructors are subject matter experts with direct industry experience. Instructors include guest speakers from industry, government and academia. Course materials are developed by PII in-house and are constantly updated to keep current with the regulatory environment. As the industry changes, so do the issues and challenges. Our courses, with supporting materials, link together: Training Regulations Government Industry Academia International Standards Conferences PharmEng offers conferences throughout the year in collaboration with Health Canada, and various professionalassociations in biotechnology, pharmaceutical, medical devices, nutraceutical and healthcare industries.

5 PHARMENG CORE TRAINING COURSES Current Good Manufacturing Practices GMP Get More Productivity GMP Concepts and Implementation cgmp s for Drugs and Active Pharmaceutical Ingredients Manufacturers cgmp training is tailored to meet your company s specific needs in one or all of the following areas: Engineering Production Packaging Quality Assurance Quality Control Regulatory Affairs Clinical Research New Drug Submission/Application Natural Health Products Active Pharmaceutical Ingredients Medical Devices Blood and Blood Products Practical cgmp Engineering Commissioning and Validation of Pharmaceutical and Biotechnology Facilities Design and Validation of Critical Utility Systems Process Analytical Technology (PAT) Design and Commissioning and Validation of Pharmaceutical and Biotechnology Facilities Quality and Compliance PharmEng also provides customized Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) training to clients in order to assist companies in moving forward with their pre-clinical and clinical trials. Master Plan Roadmap to Compliance Good Laboratory Practices (GLP) Pharmaceutical Quality Assurance and Control GMP Programs Planning and Implementation Audit Programs and Annual Review Recall and Compliant Systems Standard Operating Procedures Corrective and Preventative Actions (CAPA) Risk-based Approach to Inspecting Quality Systems Validation Analytical Methods Validation Process Validation Cleaning Validation Computer Systems Validation Validation of Sterilization Processes Project Management Project Management in a Regulatory Environment Project Management for Clinical Research Studies Medical Devices Medical Device Regulatory Requirements Quality System Requirements ISO Quality Systems for Medical Devices Manufacturing Manufacturing Control in the Pharmaceutical Related Industries Pharmaceutical and Biotech Manufacturing Processes Active Pharmaceutical Manufacturing Solid and Semi-Solid Dosage Manufacturing Aseptic Manufacturing Sterile and Septic Processes Regulatory Affairs Good Clinical Practices (GCP) New Drug Application/Submission Chemistry, Manufacturing and Control Natural Health Products Registration PharmEng Technology, a division of PE Pharma Inc., headquartered in Toronto, Canada, is a full-service consulting company that serves the pharmaceutical and biotechnology industries internationally. Consulting services include project management, engineering, cgmp, validation, calibration, regulatory compliance and certified training.

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