- PDF Free Download

Size: px

Start display at page:

Download ""

Milo Hensley
6 years ago
Views:

1 I. DEFINITION This training under Kilimanjaro School of Pharmacy Industrial Pharmacy Teaching Unit (IPTU) is an Advanced Training Program in Drug Development, Drug Manufacturing, Regulatory & Quality Compliance. II. INTRODUCTION The purpose of this advanced training program is to provide in-depth level education/ training in the important aspects of Drug Development, Drug Manufacturing, Regulatory and Quality Compliance in the Pharmaceutical Industry. Thereby, participants/students will have an opportunity to improve their knowledge of drug development, drug manufacturing, regulatory and compliance issues and to explore careers in these exciting areas in the pharmaceutical industry or related institutions. The development of this program has been a joint effort between Purdue University, USA and Kilimanjaro School of Pharmacy - St. Luke Foundation, Tanzania. Individuals who successfully complete the advanced training program will be provided a certificate of completion signed jointly by Kilimanjaro School of Pharmacy - St. Luke Foundation and Purdue University. This advanced training program consists of four courses; each involves 45 contact hours as well as associated homework assignments and examinations. The certificate program consists of the following four courses: 1. Drug discovery, 2. Drug development and regulatory & quality compliance, 3. Drug manufacturing process, 4. Regulatory documents and generic drug approval submissions. Participants in the 2012 intake will complete the Industrial Pharmacy Advanced Training Program (all four courses)in two years. III. ELIGIBILTY Requirements: An applicant for this program must be a holder of at least a bachelor s degree in Pharmacy or Biochemistry, or Chemistry or Microbiology and Food technology industries. Participants: Applicants include persons employed in the pharmaceutical industry including positions in pharmaceutical manufacturing, pharmaceutical analysis, quality or regulatory affairs. Applications from qualified persons employed in universities looking to expand their curriculum or other public institutions such as medicines regulatory authorities are also welcome. V. APPLICATION PROCEDURE Applicants must complete the application form by 30 June 2012 for August 2012 intake. The application form is provided in the annex of this brochure, last page. Please send the completed form to: Kilimanjaro School of Pharmacy; IPTU, St. Luke Foundation P.O.BOX 481 MOSHI, TANZANIA. TEL/FAX: ; zekeocha@gmail.com Short-listed / selected applicants will be contacted through . Application fee of $50 (USD) to be paid by cheque or Bank draft; payable to Saint Luke Foundation, Deadline for the completed application form with fee to reach Saint Luke Foundation by 30 June 2012, for August 2012 in-take. 1

2 VI. COURSE DURATION & STARTING DATES For each course, the duration is 14 days. The program will begin with the courses as outline below: Drug discovery August 2012 Drug development, regulatory & quality compliance, March 2013 Followed by: Drug manufacturing process August 2013 Regulatory documents and generic drug approval submissions March 2014 VII. COURSE FEES AND COSTS Application fees 50 USD non refundable Registration fees 20 USD non refundable Tuition fees, materials and examination 1,500 USD 1,500 USD per course, excluding Application fee and Registration fee. Total for the program 6,000 USD Accommodation: For the duration of the courses SLF can Organise accommodation with half board Transportation from airport (arrival & departure for 50 USD per trip. Lunch will be provided at SLF at a rate of 10 USD per day. 2

3 VIII. COURSE CONTENTS The course contents shown can vary slightly at the discretion of the instructor to meet the requirements of students. Course 1: August 6 th 18 th 2012: Drug Discovery Lecture Number Module 1 Drug Discovery 2 Drug Discovery 3 Discovery Process 4 Discovery Biologists 5 Synthetic Chemistry 6 Discovery 7 Toxicology for Discovery 8 Drugs from Biotech 9 Early Formulations 10 Patents 11 Conclusion 12 Review and Exam Module 2 Early Development and Toxicology 1 Organization and Administration 2 Toxicology 3 Contract Research 4 Ethics 5 Phase I 6 Phase II 7 Marketing and Sales 8 Product Decisions 9 Clinical Trials 10 Clinical Trials 11 Clinical Trials 12 Case Study 13 Review and Conclusion 14 Exam Module 3 Chemistry Manufacturing and Controls 1 USP 2 Pisano 3 IND 4 DMF 5 End of Phase 2 6 Specifications 7 Impurities 8 Stability 9 Case Studies 10 Case Studies 11 FDA Structure 12 Submitting an NDA/IND 13 Review and Conclusion 14 Exam Course 2: March 2013 Drug development, Regulatory & Quality Compliance Module 1 - GMP Drug Product 1 Intro to GMP 2 GMP s Cleanliness and 3 Contamination Exercise 4 Six Systems-31 5 Six Systems Exercise 6 ICHQ1 7 ICHQ2 8 ICHQ3 9 ICHQ6 10 ICHQ8 11 ICHQ9 12 QC-QA 13 QC 14 GMP s. 3

4 15 GMP s as Learning Syst. 16 SUPAC - Changes Comparability Protocols 17 SUPAC Comparability Protocols - 18 Biologicals 19 USP for GMP 20 SOPs 21 SOP Example 22 OOS 23 Computer systems GMP s and Quality by 24 Design 25 KRMPAT-I 26 KRMPAT-II 27 Review and Conclusion 28 Exam Module 2 GMP API 2 GMP s 3 Systems & CAPA Module 3 - GLP 1 Quality 2 Toxicology 3 GDRPs 4 Information 5 Quality in Discovery 6 GLP 7 QC in Tox 8 IM Tox Archives 9 QA in Tox 9 Management 9 Furrow top Regulatory Facts 11 Role of Study Director In tox 12 FDA GLP Inspections 13 Exam Module 4 - GCP Quality and Compliance 1 Clinical Research 2 What goes wrong 3 RQA GCP - defective 4 RQA Auditing 5 QC in Clinical Res defective. 6 Reg. Aff. In Clin. Res. 7 FDA GCP Inspections 8 Pharmacovigilance Summary useful things - 9 delete 10 Exam 4

5 Course 3: August 2013: Drug Manufacturing Processes & Laboratory Module 1 Drug Product 2 Preformulation Principles 3 Dimensional Analysis 4 Powder Properties 5 Mechanical Properties 6 Particle Size Reduction 7 Blending 8 Blending 9 Granulation 10 Granulation 11 Drying 12 Tableting 13 Coating 14 Coating 15 Capsules 16 Aerosol Products 17 Aerosol Products 18 Parenterals 19 Parenterals 20 Parenterals Laboratory Modules to be conducted in the Industrial Pharmacy Teaching Unit. Module 2 API Manufacturing 2 Synthesis 3 Isolation 4 Crystallization 5 Drying 6 Impurities 7 Residual Solvents 8 Cert. of Analysis Module 3 Measurements 2 Crystallography 3 XRPD 4 IR & Raman 5 Chemical Imaging. 6 Particle Size 7 Mixture Analysis 8 Crystallization Module 4 Validation 2 Cleaning validation 3 Analytical Mtd. Validation 4 Computerized system valid. 5 Qualification Syst. & Equip. 6 Product & process valid. Granulation (T) Compression (T) Coating (T) Granulation (P) Compression (P) Dissolution Characterization 5

6 Course4: March 2014: Regulatory documents, generic drug approval submissions, quality, auditing Module 1 - ANDA 1 Application 2 Bioavailability 3 Validation of HPLC Method 4 Informed consent Components and 5 composition 6 Buildings and Facilities 7 Manufacturing 8 Controls 9 Methods Validation 10 Forced degradation 11 Dissolution validation Related substance 12 validation Module 2 ANDA 1 DP Specifications 2 Specifications exercise 3 Stability 4 Final Documents 5 QOS 6 Reg. Aff. In Clin. Res. 7 Exam Module 3 Auditing/Inspections 2 Role of Inspector 3 Prep. for Inspection 4 Types of Inspections 5 The Inspection 6 Audits 7 Internal Audits 8 Exam Quality by Design 1 Current vs. Desired State 2 Materials Properties 3 Prelim. Dev. Plan 4 Design Space 5 Important Areas for QbD 6 Sensors and Chemometrics 7 Impl. and Scale-up 8 QbD and Drug Subs. 9 Exam IX. COURSE COORDINATORS For questions on registration please contact: Sr. Zita A. Ekeocha Head Industrial Pharmacy Training Kilimanjaro School of Pharmacy Saint Luke Foundation P.O. Box 481, Moshi TANZANIA. zekeocha@gmail.com For questions regarding the curriculum please contact: Stephen R. Byrn, Ph.D Charles B. Jordan Professor of Medicinal Chemistry Department of Industrial & Physical Pharmacy Purdue University 575 Stadium Mall Drive West Lafayette, IN USA. sbyrn@pharmacy.purdue.edu Joseph M. Fortunak Associate Professor Chemistry and Pharmaceutical Sciences Howard University 525 College Street NW Washington, DC USA jfortunak@comcast.net <jfortunak@comcast.net> 6

7 ST. LUKE FOUNDATION KILIMANJARO SCHOOL OF PHARMACY When completed, return form to: Course Coordinator, Industrial Pharmacy Training, KSP, P.O BOX 481, Moshi. APPLICATION FOR ADMISSION TO THE INDUSTRIAL PHARMACY ADVANCED TRAINING PROGRAM Mr./Mrs./Ms. Surname Other names Date of Birth Nationality Home or Permanent Address Telephone Number Emergency contact (BPharm, BSc etc,) Institution, Date obtained Details of work experience: Qualifications Date Employer Position Nature of work No. of employees supervised: Briefly describe/list your daily responsibilities Do you have any physical or other disability requiring special arrangements or facilities YES/NO If YES, please forward to us further details of your disability and special requirements. I certify that the information given above is correct Signature Date: Statement of Support: Name of the Sponsor (Company, institution etc) purpose of training/ special training needs State I support the application of the candidate and certify that the information given by the candidate is correct. Signature Date: Please attach the agreement on continued employment for one year following the completion of the course to this application.

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!