Annual Meetings

Training Course in the USA

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Nr.	Title
2	Quality of Biotechnology Products : Analysis of the Expression Construct in Cells Used for Productions of r - DNA - Derived Protein Products (CPMP/ICH/139/95)
4	Submitting Samples and Analytical Data for Methods Validation
5	Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant -DNA - Derived Product or a Monoclonal Antibody Product for in Vivo use, August 1996
6	Format and Content for the CMC Section of an Annual Report, 1994
8	NDAs: Impurities in Drug Substances (Feb. 2000)
9	Investigating Out of Specification (OOS) results for Pharmaceutical Production
12	Changes to an Approved NDA or ANDA, Revision 1
15	PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
16	SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
17	ORA Inspectional References Guide to Inspectors of Quality Systems, August 1999
19	Industry Survey on Current Sterile Filtration Practices
21	The Application of the principles of Good Laboratory Practice and the verification of their Application for Tests on Chemical Substances
27	Impurities in New Drug Substances
28	Impurities in New Drug Products (CPMP/ICH/282/95)
29	Quality of Biotechnology Products : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95)
30	Quality of Biotechnological Products : Stability Testing of Biotechnological / Biological Products (CPMP/ICH/138/95)
31	Quality of Biotechnological Products Derivation and Characterisation of Cell Substrates used for the Production of Bio. Products (CPMP/ICH/294/95)
32	Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
33	Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
34	Impurities: Residual Solvents (CPMP/ICH/283/95)
36	Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
38	Q3B(R2) Impurities in New Drug Products
40	Stability Testing of Drug Substances and Drug Products
42	SUPAC-IR Immediate Release Solid Oral Dosage Forms, Scale - Up and Post-approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, In Vivo Bioequivalence Documentation, Guidance November 1995
43	Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Validation
44	Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Glossary of Terms
47	Drug Master Files for Bulk Antibiotic Drug Substances
48	The Sourcing and Processing of Gelatin to reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy, December 2000
49	SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
50	Reviewer Guidance: Validation of Chromatographic Methods, 1994
54	Draft on a legislative proposal on GMP for starting materials and inspection of manufacturers of both medicinal products and starting materials
55	Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients
56	BACPAC I: Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation, February 2001
58	CPMP/QWP/122/02, rev 1 - Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
60	CPMP/QWP/155/96 Note for guidance on development pharmaceutics (CPMP adopted Jan. 98)
62	CPMP/QWP/609/96 Rev 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003), Rev 2 withdrawn
65	CPMP/QWP/158/96 Note for guidance on dry Powder Inhalers
68	CPMP/QWP/054/98 Annex to Note for guidance on Development Pharmaceutics (CPMP/QWP/155/96): Decision Trees for Selection of Sterilisation Methods
78	Manufacturing, Processing Or Holding of Active Pharmaceutical Ingredients (APIs), March 1998
79	Computerized Systems used in clinical trials-Draft
80	Drug Master Files, September 1989
84	Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
90	Guideline for the Manufacture of Active Pharmaceutical Ingredients (PH 2 / 87 )
91	Aide-Memoire for the inspection of blood donation and plasmapheresis
94	Guidelines for the manufacture of veterinary medicinal products
96	Good Manufacturing Practices : Guidelines on the Validation of Manufacturing Processes (in WHO Technical Report Series 863, 1996)
102	Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-3) Sept 2007
104	Resolution AP-CSP(99)4 des Council of Europe, Public Health Committee
105	ISPE Baseline Guide Bulk Pharmaceutical Chemicals Pharmaceutical Engineering Guide
108	Aseptic processing of health care products- Part 1: General requirements
109	Validation of Aseptic Processing (PI 007-5) 2009
110	Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
111	Validation of Computer-related Systems TR 18
112	Inspection of Computer Systems
113	Validation and Qualification of Computerized Laboratory Data Acquisition Systems
114	GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach
115	21 CFR Part 211 Current Good Manufacturing Practice
116	Guide to Inspections of Computerised Systems in Drug Processing, February 1983
117	21 CFR Part 11 Electronic Records, Electronic Signatures
118	Human Drug CGMP Notes
119	Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
120	Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008
121	Annex 2: Manufacture of Biological Medicinal Products for Human Use
122	Annex 3: Manufacture of Radiopharmaceuticals (Revision September 2008)
124	Annex 5: Manufacture of Immunological Veterinary Medicinal Products
125	Annex 6: Manufacture of Medicinal Gases
127	Annex 8: Sampling of Starting and Packaging Materials
128	Annex 9: Manufacture of Liquids, Creams and Ointments
129	Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
130	Annex 11: Computerised Systems Draft
131	Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
138	Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
139	Design Concepts for the Validation of a Water-for-Injection System
140	Sterile Pharmaceutical Packaging: Compatibility and Stability
141	Depyrogenation
142	Review of Commercially Available Particulate Measurement Systems
143	Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers
144	Sterilization of Parenterals by Gamma Radiation
145	Siliconization of Parenteral Drug Packaging Components
146	Fundamentals of a Microbiological Environmental Monitoring Program
147	Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins
148	Industrial Perspective on Validation of Tangential Flow Filtration in Bio-pharmaceutical Application
149	Effect of Gamma Irradiation on Elastomeric Closures
150	Current Practices in the Validation of Aseptic Processing
151	Rapid/Automated ID Methods Survey
152	Report on Survey of Current Industry Gowning Practices
153	Bioburden Recovery Validation
154	Design And Validation Of Isolator Systems For The Manufacturing And Testing Of Health Care Products
155	Contamination Risks in the Manufacture of Parenterals
156	Inspecting the Manufacture of Sterile Products, Current and Future Trends
158	Annex 1: Manufacture of sterile Medicinal Products, PDA Commentary
159	Recommendations on Sterility Testing (PI 0012-3) Sept 2007
160	Process Simulation Testing for Aseptically filled Products
161	Sterilizing Filtration of Liquids
162	Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat
163	ISPE Baseline Guide: Biotech
164	ISPE Baseline Guide: Guide Water and Steam Systems
165	ISPE Baseline Guide: Oral Solid Dosage Guide
166	ISPE Baseline Guide: Sterile Manufacturing Facilities
167	ISPE SUPAC Guide (Similar Equipment)
170	Validation of Steam Sterilisation Cycles: Technical Monographs Nr. 1
171	Current Practices in the Validation of Aseptic Processing
172	Blend Uniformity Analysis: Validation and In-Process Testing
173	Points to Consider for Cleaning Validation
174	Pharmaceutical Package Integrity
175	PDA - Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
176	Annex 15: Qualification and Validation
177	Annex 16: Certification by a Qualified Person and Batch release
178	Annex 17: Parametric Release
180	ISPE Baseline Guide: Commissioning and Qualification
181	ISPE Baseline Guide: Packaging and Warehousing
206	General Principles of Process Validation´, May 1987
207	Guide to Inspections of Cosmetic Product Manufacturers, February 1995
208	Guide to Inspections of Oral Solutions and Suspensions, August 1994
209	Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994
210	Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 1994
211	Guide to Inspections of Dosage Form Drug Manufacturers, October 1993
212	Guide to Inspections of Validation of Cleaning Processes, July 1993
213	Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993
214	Guide to Inspections of High Purity Water Systems, July 1993
215	Guide to Inspections of Lyophilisation of Parenterals, July 1993
216	Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993
217	Guide to Inspections of Topical Drug Products, July 1994
218	Sterilization Process Validation, January 1993
220	Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
221	Biotechnology Inspection Guide, November 1991
223	Compliance Policy Guides - Enforcement Policy: 21 CFR Part 11, Electronic Records; Electronic Signatures (CPG 7153.17)
257	Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests
259	Validation for Medical Devices and Diagnostic Manufacturers
261	Evaluation, Validation and Implementation of New Microbiological Testing Methods
262	PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S 1/95(Rev.4)) November 2007
267	Principles of Qualification and Validation in Pharmaceutical Manufacture
268	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Electronic Copies of Electronic Records
269	Note for Guidance on Process Validation
270	ISO 13683 Sterilization of health care products
271	Medical devices -- Application of risk management to medical devices - Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte
273	Quality systems Medical devices - Particular requirements for the application of ISO 9001
276	FIP Guidelines for Dissolution Testing of Solid Oral Products
280	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Time Stamps
281	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Maintenance of Electronic Records
283	Note for Guidance on Start of Shelf-Life of the Finished Dosage Form
285	Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products
286	Note for Guidance on Medicinal Gases: Pharmaceutical Documentation
287	Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products
288	Note for Guidance on Quality of Water for Pharmaceutical Use (Rev.)
290	Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation
292	Guideline on the Investigation of Bioequivalence
295	Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
298	Note for Guidance on Impurities: Residual Solvents - Permissible Daily Exposure for Tetrahydrofuran and N-Methylpyrrolidone
299	Note for Guidance on Impurities in New Drug Products
319	Certificate of Pharmaceutical Product - Application Instructions -
322	Standard Abbreviations (Acronyms)
325	Preamble to Title 21, Subchapter C, Human and Veterinary Drugs, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding
326	21 CFR Part 800 Medical Devices - General
327	21 CFR Part 820 (Quality System Regulation)
328	21 CFR Part 7 Enforcement Policy
329	21 CFR Part 600 Biological Products: General
330	21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
331	21 CFR Part 610 General Biological Products Standards
332	21 CFR Part 314 Applications for FDA approval to market a new drug
333	21 CFR Part 314.81 Other Postmarketing Reports (including Annual Report)
334	21 CFR Part 312 Investigational New Drug Application
340	Glossary of Computerized System and Software Development Terminology
342	Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
344	Guide to Inspections of Medical Device Manufacturers (12/97)
358	Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
378	Guide to International Inspections and Travel
379	Compliance Program Manual
380	Medical Device Reporting: An Overview
381	Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (02/2001)
382	Compliance Program Guidance Manual 7356.002 Drug Manufacturing Insections (02/2002)
383	ISPE Good practice Guide Commissioning and Qualification of Pharmaceutical Water and Steam Systems
387	Guide to Inspections of Quality Systems (08/99)
388	Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management
467	DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
468	"Do It By Design: An Introduction to Human Factors in Medical Devices"
470	Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
471	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
475	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
479	Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolided version: 30/12/2008).
481	Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
482	2001/20/EC - Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use - English Version
485	Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
490	Alternative to Certain Prescription Device Labeling Requirements
492	Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
494	Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA
495	Guide to Inspections of Medical Device Manufacturers
496	Guide to Inspections of Infectious Disease Marker Testing Facilities
497	Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
498	Premarket Approval Manual
500	HHS Publication FDA 96-4159 - Investigational Device Exemptions Manual
501	Medical Device Reporting for Manufacturers
502	In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
510	Environmental Assessment of Human Drug and Biologics Applications
511	Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
518	SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
519	SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation
522	Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances
523	Submitting Documentation for the Manufacture of and Controls for Drug Products
526	Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances