An Interactive Two-Day Program. Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements

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1 An Interactive Two-Day Program Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements REGISTER EARLY! Mainz, Germany October 2015 Hyatt Regency Mainz Program produced by ats e s d e t i Lim available Program sponsored by

2 ABOUT THE PROGRAM The program will allow ample opportunity for individual questions to be answered by the presenters, who are known as some of the nation s foremost experts on GMP matters. Like all Pharma Conference programs, this program will be an informal, relaxed learning session to help improve your performance at work. Attendees will receive not only basic regulation information, but practical utilization techniques, as well. Register early, since this program is limited in size and always fills up. WHO SHOULD ATTEND? Anyone involved in production, quality assurance, quality control, regulatory affairs, or auditing in the pharmaceutical and biopharmaceutical industry in Regulatory and GMP matters. Supervisory personnel and managers can enhance Regulatory and GMP performance by sending production, quality, and regulatory personnel to this learning experience. They will gain a significant appreciation of GMP requirements and the importance of utilizing and considering GMP matters in all of their day-to-day operations. WHY ATTEND? To gain a better understanding of how the Regulatory Authorities look at your operations and how to anticipate problem areas before they create problems for your company To take advantage of the knowledge of seasoned experts who have been there and done that To obtain current information about FDA activities To get those cgmp questions that cause you sleepless nights answered by the experts ABOUT THE VENUE Strategically situated at the confluence of the Rhine and Main Rivers, Mainz has a sizable university, fine pedestrian precincts and a certain savoir vivre whose origins go back to Napoleon s occupation ( ). Strolling along the Rhine and sampling local wines in a half-timbered Altstadt tavern are as much a part of any Mainz visit as viewing the fabulous Dom, Chagall s ethereal windows in St-Stephan-Kirche, or the first printed Bible in the Gutenberg Museum, a bibliophile s paradise. Mainz has been the capital of the German federal state of Rhineland-Palatinate since CONTINUING EDUCATION CONTINUING EDUCATION The University of Maryland School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This knowledge-based activity meets the ACPE criteria for continuing education credit. Statements of credit will be mailed within 60 days to those participants who successfully complete the activity. Successful completion requires participation at the entire activity and completion of a activity evaluation form. No partial credit will be awarded.

3 THE SPEAKERS Gary Bird, PhD Dr. Bird is currently President, PharmaConsult-US, LLC, and Managing Partner, PharmaConsult Global, Ltd., an international cooperative supplying GXP quality consulting services. He served as Director of Corporate Quality for GTx, Inc. (Memphis, TN, USA) from 2003 until 2013 and was responsible for confirming all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) related activities were conducted in compliance with appropriate laws and regulations. He has held previous positions with Eli Lilly and the FDA where he represented both PhRMA and the FDA in the International Conference on Harmonization negotiations on four different agreed guidances. John DR Jolley, FR Pharm S, FCQI CQP.RSC. Mr. Jolley is a Pharmaceutical Consultant providing technical consultancy and training in European countries, the Middle East, South Africa and the USA. He is a practicing pharmacist who has held positions in Clinical Research, Product Registration, Manufacturing, Quality Assurance, and General Management. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations and is an Industry representative on the EMA advisory committees for GMP/GCP. He has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society and is Registered as a Senior Consultant to carry out GXP audits and deliver training for candidates wishing to qualify for the Diploma in Quality Management and membership of The Chartered Quality Institute. Anthony Newcombe, PhD FRSC Dr. Newcombe is the Principal Consultant, Strategic Compliance, PAREXEL and has almost 20 years post-graduate experience in academia and industry. He has extensive knowledge of product development, process validation and GMP compliance across a broad range of biological and biotechnological products including monoclonal antibodies, recombinant proteins and vaccines. Prior to joining PAREXEL, he was Head of Process & Product Validation, Global Industrial Operations, GlaxoSmithKline Biologicals, where he was responsible for ensuring GMP compliance with rules and regulations governing biologics manufacture for US and EU distribution and was also involved with the interaction with regulatory agencies regarding marketing authorisations and post-approval variations. Prior to joining GSK, he was a member of the Technical Leadership Team at Pfizer Biotechnology Ireland. Previous to this he held additional positions in industry where he was the Process Science Manager at Protherics Ltd and prior to that was a Purification Scientist at Lonza Biologics, UK. Laurie P. Norwood, BS, MS Ms. Norwood is the Deputy Director for the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality/ CBER/FDA. She joined CBER in 1986 and worked in a research development lab for nine years, receiving two patents for her work on in vitro potency testing for Oral Polio Virus Vaccine. Since joining OCBQ in 1995, her responsibilities have included review of INDs for emerging Cellular and Gene Therapy products, license applications, and supplements for viral vaccines, hematologic recombinants, in vitro diagnostic kits and blood fractionation products, as well as inspection of biological manufacturing facilities. She has managed reviewers within the division and in addition to her Deputy Director responsibilities is currently involved in policy and development of guidance documents related to the review and inspection of products regulated by CBER. Jeff Odum, MS Mr. Odum is Director of Operations/Biotech Sector Lead for Integrated Project Services (IPS). He has more than 25 years of management experience in the design, construction, and commissioning of facilities in the biotechnology and pharmaceutical industries. Throughout his career, he has been involved in managing conceptual design, detailed design, preconstruction, construction, start-up and validation support for projects ranging in size from $1 million to more than $2 billion. A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. Mr. Odum is also a globally recognized instructor in the areas of facility design, GMP compliance, and aseptic manufacturing. He has led training efforts in 15 countries, as well as in the US. He is a Teaching Fellow in North Carolina State University s BTEC graduate program in Biomanufacturing and is a member of ISPE s technical training faculty. AGENDA Tuesday, 13 October 2015 Morning Session Moderator Anthony Newcombe 7:30 8:30 Registration 8:30 8:35 Welcome 8:35 9:15 Biotech and Biosimilar Drug Products: Gary Bird, PhD GMP and Regulatory Requirements 9:15 10:00 Expectations for a Biopharmaceutical Quality Management John Jolley System for GMP Compliance To receive s on our upcoming programs, add to your address book.

4 AGENDA 10:00 10:20 Break* 10:20 10:50 The Biotech Facility: Jeff Odum Design Issues for Dedicated and Multi-Product Facilities 10:50 11:30 Inspections of the Biotech Manufacturing Facility and Process Laurie Norwood 11:30 12:00 Case Study Session #1 Team 12:00 13:30 Lunch* Afternoon Session Moderator Jeff Odum 13:30 14:00 Managing and Controlling the Quality Management System John Jolley Supplier Qualification, PAT, Outsourcing, Change Control 14:00 14:30 How Well is Your Biotech Process Performing? John Jolley Quality Metrics for Biopharmaceuticals 14:30 15:00 Break* 15:00 15:20 Facility Issues: Water, Contamination Control, CIP/SIP, and HVAC Jeff Odum 15:20 16:00 Equipment Selection in the Biotech Facility: Jeff Odum Permanent or Disposable? 16:00 17:00 Case Study #2 and Group Discussion: Team Bring Your Questions for Open Discussions Wednesday 14 October 2015 Morning Session Moderator Gary Bird, PhD 8:30 8:35 Welcome 8:35 9:15 Cell Banking, Expansion, and Growth: Anthony Newcombe Issues for Technical and Regulatory Compliance 9:15 10:00 Separation, Filtrations, and Contamination Removal/Inactivation: Anthony Newcombe Key Biotech Process Attributes and Inspectables: 10:00 10:20 Break* 10:20 10:50 Downstream Purification: Key Biotech Process Anthony Newcombe Attributes and Inspectables 10:50 11:30 Viral Clearance Issues in the Biotech Process Anthony Newcombe 11:30 12:00 Environmental Monitoring: Gary Bird, PhD Creating a Proper Program for Compliance Afternoon Session Moderator Gary Bird, PhD 13:30 14:00 Cold Chain Distribution and Good Distribution Practices John Jolley 14:00 14:30 Auditing for Effect: Creating a Strong Early Warning, Gary Bird, PhD Compliance System 14:30 14:50 Break* 14:50 15:20 Successful Deviation Investigation: Critical Elements to Consider John Jolley 15:20 16:00 Case Study #3 and Group Discussion: Team Bring Your Questions for Open Discussions Dismissal *Denotes non-educational activity

5 REGISTRATION Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements CLICK HERE TO REGISTER ON OUR SECURE SERVER Register early and SAVE! FEES Payment Received By 14 August 2015 Payment Received After 14 August 2015 q $1695USD q $1895USD Includes program materials, continental breakfasts, coffee breaks, and lunches per agenda Cancellation Policy: 30 days or more for a full refund less $250 cancellation fee; under 30 days, no refund, but attendee substitutions may be made at any time. Cancellations and substitutions must be made in writing to Pharma Conference ( In the event of any civil disorder, extremely adverse weather conditions, or other Acts of God, Pharma Conference reserves the right to reschedule the meeting dates in the interest of attendee safety. PAYMENT Full payment may be made by credit card or company check Checks must be received within 15 days of receipt of registration form. Checks should be made payable to Pharma Conference Inc, in U.S. dollars and drawn on a U.S. bank. Registrations will be confirmed when full payment has been received. Taxpayer ID # Registrations made within 30 days of conference start date must be accompanied by full payment. Checks should be sent to Pharma Conference Inc at the following addresses (see check instructions above): Airmail to: P.O. Box , Kerrville, Texas USA Express to: 819 Water Street, Suite 350, Kerrville, Texas USA HOTEL Hyatt Regency Mainz Hyatt Mainz GmbH Malakoff-Terrasse Mainz Germany Telephone: Ask for the booking by the name of Pharma Conference Inc or Reservation Number: JWS1 Single Euro 171 Double Euro 196 A limited number of rooms have been blocked at the special rates listed per night. Hotel reservations must be made on or before October 4, 2015, in order to guarantee the special rate. Individuals are responsible for making their own hotel reservations. Ask for the booking by the name of Pharma Conference Inc or Reservation Number: JWS1 in order to obtain these special rates. Please do not use travel agents for reservations. For additional information, contact Pharma Conference Inc: (830) Fax: (830) CLICK HERE TO REGISTER ON OUR SECURE SERVER

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