An Introduction to Double Dragon Consulting
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1 An Introduction to Double Dragon Consulting 1 June 2012
2 About DDC Our Experience: All dosage forms, aseptic processes, OTC Remediation of 483 observations, warning letters, consent decrees All phases of operation from construction, commissioning, and maintenance of aseptic processing facilities International (US, EU, Asia) Our Offices Headquarters in North Carolina Representative Office in Shanghai, PRC Our Associates Global network of experienced independent consultants 2
3 Clients Novartis Vaccines (US, EU, China) Novartis Pharma Novartis Consumer Health GSK Schering Plough Sandoz (EU) Genentech Hospira URL Mutual Washington Homeopathic Products Teva Forest Research Institute MedImmune Sanofi Pasteur Merck Cardinal Health Bayer Hoffmann LaRoche Steifel NuPathe ClinAudits Marianna Vertellus CibaVision 3
4 DDC Principal Stephen Sheng, MSQA Principal Double Dragon Consulting MS Quality Assurance, BS Biochemistry ASQ Certified Quality Auditor and Certified Quality Engineer 24+ years of Pharma experience Wide Range of experience: OSD, Injectables, Vaccines, Medical Devices, APIs, and Dietary Supplements 483, Warning Letter, and Consent Decree Remediation Investigations and CAPAs Aseptic Operator Training Supply Chain and Supplier Qualification Customer complaints Annual Product Reviews Audits for ISO 13485, MDD, and CE Marking Project Management 4
5 DDC Principal George S. Bernstein, Ph.D. Principal Double Dragon Consulting Ph.D. in Chemical Engineering 25+ years of Pharma experience Wide range of experience: Quality Systems Development, Remediation, FDA communications GMP, GCP, GLP, GPP Quality Guidelines Operational Excellence Training Project/Program Management Facility Construction and Commissioning Investigations / Root Cause Analysis Business Process Re-engineering 5
6 Our Philosophy Experienced Professionals We provide consultants with the right expertise and experience from our global network to meet your needs subject to your review and approval Flexibility: Work can be performed on site or remotely via Internet Sustainability Our goal is to transfer our knowledge to your company so that together we achieve a sustainable solution 6
7 DDC Capabilities Quality and Validation support Training Regulatory Engineering Project Management Technical analytical method development 7
8 DDC Capabilities Quality and Validation Support Lead all aspects of compliance remediation activities Conduct deviation / product or lab failure investigations Evaluate / develop procedures, processes, and documentation to meet US and EU requirements Prepare Validation Master Plan Prepare / evaluate / execute validation protocols (process, equipment, cleaning, analytical methods, etc.) Third Party independent review of deviation, change control, and validation reports Evaluate change control, deviation, and validation reports Conduct audits / compliance gap assessments 8
9 DDC Capabilities Training Aseptic Operations including Gowning Qualification Deviation Management, Root Cause Analysis, CAPAs Internal Audits GMP regulations (US, EU, China) Technical Writing 9
10 DDC Capabilities Regulatory Prepare / review regulatory (IND, NDA, ANDA) submissions Prepare / review CMC sections of regulatory submissions Perform risk assessment and crisis management Perform mock Pre-Approval Inspection (PAI) Establish PAI action plan and execute remediation activities 10
11 DDC Capabilities Engineering Prepare conceptual designs / review designs for pharmaceutical manufacturing facilities, to include personnel and materials flows, facility layouts and manufacturing processes, HVAC system, utilities, automation system Provide expert guidance on Class A/B Cleanroom design to meet US, EU, and China requirements Provide guidance on Equipment Qualification and Commissioning Establish routine / preventive maintenance programs 11
12 DDC Capabilities Project Management Develop Project Plan with milestones, timelines and resources Establish and run a project management office (PMO) Establish / maintain work stream status reporting and tracking system Marketing Provide guidance or assist in product launch in China Identify qualified contract manufacturer in China Search for in-license/out-license opportunities in China 12
13 Projects Experience 1 Novartis Vaccines & Diagnostics Location: China Year: Work Scope: Aseptic Operations, Supply Chain, Technical Transfer, and Engineering projects (bulk, fill/finish, QC). Deliverables/Outputs: Successfully led remediation projects for bulk, fill/finish, packaging, warehouse, and QC Lab areas including construction, equipment selection and procurement, commissioning and qualification, and process validation. Established training materials and provided training to hundred of employees on aseptic processing and techniques including gowning qualification and environmental monitoring. Recommended the selection of aseptic filling lines and critical equipment. Completed installation, commissioning, qualification and validation, which covers syringe filler, vial filler, aseptic filling suite, QC sampling suite, packaging area, & critical utility systems. Successfully supported the daily functions within Engineering and Supply Chain departments. 13
14 Projects Experience 2 Training Projects (Merck, Sanofi, Sandoz) Location: US, EU Year: Work Scope: Aseptic Operations, formulation, bulk, fill/finish, QC, warehouse). Deliverables/Outputs: Led project to evaluate compliance risk and to recommend improvements to training organization, training processes, and training effectiveness. Led effort to evaluate/develop training materials for Operations, Deviation Management, and shop floor Quality Assurance departments. Acting as interim head of training for parenterals company to ensure training compliance and to improve the effectiveness of training materials. 14
15 Projects Experience 3 Compliance/Remediation Projects (Hospira, Sandoz, WHP, CibaVision) Location: US, EU Year: Work Scope: Aseptic Operations, QA, Deviations Management. Deliverables/Outputs: Acted as 3rd party reviewer of parenteral manufacturer s deviation investigations, performed as a part of company s warning letter remediation. Role included coaching and mentoring. Led QC lab compliance remediation effort for a medical device manufacturer. Project included QC audits and project plan development. Led warning letter remediation project for small OTC manufacturer. Project involved training, documentation redesign, cleaning validation studies and direct interaction with the company owners and FDA. Prepared response letter and periodic updates to US FDA following receipt of 483 observations. 15
16 Projects Experience 4 Novartis Vaccines & Diagnostics Location: EU Year: Work Scope: Deviations Management and Training Deliverables/Outputs: Reviewed hundred of deviation reports for adequacy, completeness, and GMP compliance. Developed and implemented qualification and mentoring programs for investigators and QA reviewers. Mentored and qualified 50+ investigators and QA reviewers. Established training materials and provided training to hundred of employees on investigations, root cause analysis, and CAPAs. Company successfully passed 2 FDA inspections. 16
17 Projects Experience 5 Sanofi Pasteur Location: US Year: 2008 Work Scope: Aseptic Operations (validation, bulk, fill/finish, QC). Deliverables/Outputs: Validation of vaccine facility developed Basis of Design documentation for sterile syringe filling facility that utilized high speed syringe filler with Restricted Access Barrier System (RABS) or Isolator technology. Developed process flow diagrams for new manufacturing processes which were used to evaluate process robustness and SOPs. Developed sample coordination process to ensure that all samples collected for cleaning, process, and equipment validation were accounted for. 17
18 Projects Experience 6 GSK Location: Puerto Rico Year: Work Scope: Consent Decree (CD) Project. Deliverables/Outputs: Performed third party certification of all manufacturing deviations, OOS investigations, and customer complaints. Reviewed and certified investigation reports for adequacy and GMP compliance. Established and implemented a tracking system for all deviations reviewed. Provided quarterly updates to FDA. Mentored all investigators and QA reviewers. Company successfully passed FDA inspection and released from CD. 18
19 Projects Experience 7 Schering Plough Location: Puerto Rico Year: Work Scope: Consent Decree Project. Deliverables/Outputs: Successfully led a team to investigate and close 100+ manufacturing deviations. Successfully led Deviation Management System remediation projects including the re-design of the TrackWise system. Performed in-depth organizational assessment of entire site s ability to manage deviations (investigations and CAPAs). Established training materials and provided technical writing training to hundreds of employees. (Company successfully passed FDA inspection and released from CD.) 19
20 Summary Efficiency We employ a Right First Time approach We will delivery your project on time and within budget Quality We will focus on knowledge transfer to your people Together, we will build a sustainable Quality System Compliance We have the knowledge of US, EU and China GMP requirements We have the technical expertise in all dosage forms We will help you get there and stay there LET US PUT OUR TEAM TO WORK FOR YOU 20
21 Contact Information Phone US: +1 (919) or +1 (626) China: Website 21
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