Tagungen und Workshops zum Thema Legislation in der Medizin und Pharmakologie

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ALLE LÄNDER (20)
1
FDA Recalls - Before You Start, and After You Finish
06. Mai 2021 - 07. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it."
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
FDA Recall, FDA recall classes, FDA recall guidance, FDA recall procedures, regulatory management, CAPA, FDA inspection, Recall Regulations, Mandatory recall actions, 21 C.F.R. Part 810, 21 C.F.R. Part 806
Eintrags-ID:
1420849
2
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
10. Mai 2021 - 11. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
pharmacovigilance audit strategy planning, good pharmacovigilance practices, pv audit strategy plan, risk based pharmacovigilance audits, pharmacovigilance audit plan, fda pharmacovigilance audits, pharmacovigilance audit checklist, pharmacovigilance auditing training, fda pharmacovigilance inspections
Eintrags-ID:
1420782
3
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
10. Mai 2021 - 11. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Cleanroom regulations, Cleanroom classifications, Cleanroom design considerations, Cleanroom qualification, Cleanroom cleaning validation IOQ/PQ, Cleanroom Routine Monitoring and Excursion Investigation, Cleanroom Environmental Monitoring Program, Environmental Monitoring Program, Cleanroom Monitoring, Excursion Investigation and Trending of Data, Cleanroom Personnel Training, Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures, Cleanroom Trafficking, Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program, Sterilization Processes- Physical and Chemical Processes, basic concept of microbiology, microbiological and contamination control practices.
Eintrags-ID:
1420792
4
Data Integrity Compliance for Computer Systems Regulated by FDA
11. Mai 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
gxp systems, gmp, glp, gcp, probability of occurrence, severity of impact, detectability, mitigation, procedural controls, technical controls, risk scenario, risk assessment, risk rating, risk management, gamp 5 system categorization, good documentation practices, quality assurance, data integrity, alcoa (attributable, legible, contemporaneous, original or “true” copy, accurate), system and data governance, fda warning letter, fda consent decree, validation planning and execution, installation qualification (iq), operational qualification (oq), performance qualification (pq), fda regulations, fda trends and influences, fda oversight, computer system validation (csv), system development life cycle (sdlc) methodology, 21 cfr part 11 (electronic records/ electronic signatures)
Eintrags-ID:
1420875
5
REACH and RoHS Compliance: Gain a Deeper Understanding
17. Mai 2021 - 18. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This 2 day virtual seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
rohs and reach compliance, reach rohs compliance, reach and rohs training, difference between reach and rohs, reach & rohs, reach rohs compliance training, reach/rohs, reach compliance, rohs and reach compliance declaration
Eintrags-ID:
1420852
6
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
17. Mai 2021 - 18. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Analytical methods used for GxP purposes should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.

Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures. Lifecycle management has also been the subject of recent FDA and ICH publications.

This 2-day seminar will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols.

Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance, documentation, ICH Q2, USP chapters 220, 1200, 1210, 1220, USP, >, GLP, GCP, GMP, FDA Warning Letters, Part 11, Annex 11, LOD, LOQ, HPLC to UHPLC, INDA, ANDA, NDA submissions, QbD, statistical evaluation, Training by, Analytic Lab workshop
Eintrags-ID:
1420840
7
Change Control Best Practices - Avoiding Unintended Consequences of Changes
18. Mai 2021 - 19. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This seminar will help all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply Change Control best practices. Key focus will be placed on change proposals, justification / risk assessment and change execution / implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Techniques for assuring robust Change Control programs in light of COVID-19 restrictions will also be discussed.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Change control process, change execution plan, fda change control expectations, fda 483, warning letter citations, change control best practices
Eintrags-ID:
1420938
8
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
20. Mai 2021 - 21. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
The quality department within companies is responsible for nearly all activities to various degrees that have impact on the quality, safety or efficacy of the final product or material produced. It is also responsible for helping assure that contracted services, which is more common today than ever before, are also verified to meet the quality standards set both by the company and the regulatory requirements. The training will review special topics of interest to auditors such as CAPA programs and investigations that address deviations and out of specification (OOS) results. Attendees will be given ample opportunity to ask questions, discuss actual case studies and to learn about the vast scope of responsibility that the quality system regulations expect and the roles of their own positions..
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
FDA audit seminar, quality assurance practices, internal audit, vendor audit, third party audit, regulatory audit, CAPA programs, investigations, out of specification (OOS) results, quality system requirements (QSR), FDA 21 CFR parts 210-211 and 820, data integrity
Eintrags-ID:
1420904
9
Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan
25. Mai 2021 - 26. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Performing a corporate wide Risk Assessment can seem like a daunting task for an organization. In reality, it can be done using a template and brainstorming with internal auditors, certified fraud examiners and business unit leaders throughout your organization. Understanding your Company’s Risk Environment is key to having an effective Internal Audit organization and understanding where to focus resources, it helps to have significant experience in internal auditing and a mind for coming up with “what could go wrong” in any control environment. The corporate wide risk assessment can be performed to maximize the efficiency and effectiveness of any organization with a diligent template and process for performing the assessment and presenting it to executive management and the Board. This seminar will equip you with a methodology that has been utilized in a robust internal audit department for a Billion dollar revenue Corporation.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
annual internal audit plan, internal audit training, risk assessment, fraud risk assessment, operational risk assessment, sarbanes oxley risk, control matrix, risk and control matrices, audit plan
Eintrags-ID:
1420892
10
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
26. Mai 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
global medical device regulations seminar, medical device single audit program mdsap, GMP audit, mdsap audit, device classification, licensing pathways, medical device gmp, device labeling, medical device single audit program, medical device single audit program mdsap, fda medical device single audit program, medical device single audit program canada
Eintrags-ID:
1420957
11
Root Cause Analysis - The Heart of Corrective Action
26. Mai 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Root cause analysis, quality management system, CAPA, corrective action, risk management, risk analysis, FDA compliant CAPA, process control,
Eintrags-ID:
1420911
12
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
01. Jun 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Medical Device Single Audit Program (MDSAP), mdsap audit checklist, mdsap audit model, what is mdsap audit, mdsap guide, mdsap guidance, mdsap training
Eintrags-ID:
1420921
13
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
08. Jun 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
21 CFR Part 820, 21 cfr 820 training, 21 cfr 820 training requirement, fda qsr training, Quality System Inspection Technique, Quality System Regulation, FDA device requirement, ISO 14971, IEC 62366-1, dual QMS
Eintrags-ID:
1420975
14
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
08. Jun 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
gxp systems, gmp, glp, gcp, 21 cfr part 11, electronic records (er), electronic signatures (es), probability of occurrence, severity of impact, detectability, mitigation, procedural controls, technical controls, risk scenario, risk assessment, risk rating, risk management, gamp 5 system categorization, good documentation practices, quality assurance, data integrity, alcoa (attributable, legible, contemporaneous, original or “true” copy, accurate), system and data governance, fda warning letter, fda consent decree, validation planning and execution, installation qualification (iq), operational qualification (oq), performance qualification (pq), fda regulations, fda trends and influences, fda oversight, computer system validation (csv), system development life cycle (sdlc) methodology
Eintrags-ID:
1420974
15
Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
17. Jun 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
verification and validation, statistical elements, sample size, confidence intervals, statistical process control charts, process capability indices, confidence/reliability calculations, tests of significance, mean time between failure (mtbf) studies
Eintrags-ID:
1420973
16
Method Development and Validation for Assays Supporting Testing of Biologics
24. Jun 2021 - 25. Jun 2021 • SanJose, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing.

This 2-day virtual seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day virtual seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

Kontakt:
Tel.: [Attend this biologics seminar to learn essential concepts related to cell-based potency methods, ELISA, immunogenicity methods, analytical CMC methods, cell culture procedures, immunogenicity methods, and biomarker validation.];     Email: referral@complianceonline.com
Themen:
Attend this biologics seminar to learn essential concepts related to cell-based potency methods, ELISA, immunogenicity methods, analytical CMC methods, cell culture procedures, immunogenicity methods, and biomarker validation.
Eintrags-ID:
1420967
17
Phytotherapie 2021 — Phytotherapiekongress 2021: 50 Jahre GPT
24. Jun 2021 - 26. Jun 2021 • Bonn, Deutschland
Veranstalter:
Gesellschaft für Phytotherapie e.V.
Zusammenfassung:
Thema des Kongresses ist die pharmazeutische und pharmakologische Grundlagenforschung zu Arzneipflanzen und im Besonderen die klinische Forschung mit pflanzlichen Arzneimitteln im Sinne einer evidenzbasierten Medizin. Er richtet sich an Ärzte, Apotheker, Angehörige aller anderen Heilberufe und an Naturwissenschaftler. Der Kongress unterstützt somit die Sammlung, Erarbeitung und Auswertung von wissenschaftlichem Erkenntnismaterial für die therapeutische Anwendung von Arzneipflanzen, deren Inhaltsstoffen und Zubereitungen. Wichtiges Ziel ist die Unterstützung des selbstverantwortlichen Handelns des Bürgers für seine Gesundheit. Er stellt deshalb der Öffentlichkeit sachgerechte und verständliche Informationen zur Selbstmedikation zur Verfügung, zeigt aber auch deren Grenzen auf.
Kontakt:
Tel.: [+49 (0)228 365640];     Email: info@phytotherapie.de
Themen:
Phytotherapy, Herbal Medicinal Products, Medicinal Plant, Integrative Medicine, Regulatory Affairs.
Eintrags-ID:
1361853
18
ICPPN Germany 2021 — INTERNATIONAL CONFERENCE ON PHARMACY AND PHARMA NETWORKS
28. Jun 2021 - 30. Jun 2021 • Germany, Deutschland
Veranstalter:
ICPPN Germany 2021
Zusammenfassung:
ICPPN Germany 2021 welcomes all participants throughout the world to attend the International Conference on Pharmacy and Pharma Network held on June 28-30, 2021 in Germany. The Conference deals with the theme on "Recent Innovations and Advances in Pharmacy and Pharma Networks" and it has a branch of Scientific Sessions concerned with the departments of Pharmacology, Pharmacognosy, Toxicology, Pharmaceutical Sciences, Clinical Pharmacy, Biopharmaceutics and which included with subdivisions they are Hospital Pharmacy, Industrial Pharmacy, Pharmaceutical Biotechnology, Medicinal Chemistry, Pharmaceutical Nanotechnology, Pharmaceutical Microbiology. Pharma Germany 2021 is a chance to extend and exhibit your ideas and explore the new innovations with experts from everywhere throughout the globe. The Conference serves researchers from academia and industry and intended to be of interest to a broad audience of Pharmaceutical, Medical and Health professionals, Worldwide pharmacists, Professors, researchers, they will present their novel research and provide an insight to the current research and future expansions in pharmacy and pharma network.
Kontakt:
International Conference on Pharmacy and Pharma Network;     Tel.: [+601650835772];     Email: sandrauman28@gmail.com
Themen:
Pharmacognosy, Pharmaceutical Nanotechnology and Nanomedicine, Pharmaceutical Jurisprudence, Medicinal Chemistry, Industrial & Pharmacy Practice, Pharmacogenetics and Genomics, Bio-Pharmaceutics, Pharmacology, Community Pharmacy, Clinical Pharmacy, Pharmacovigilance, Pharmaceutical Manufacturers Global cGMP Compliance, Pharmaceutical Biotechnology Pharmaceutical Microbiology, Pharmacy and Pharmaceutical Sciences, Immunotherapy and Vaccines in Drug delivery, Pharmacotherapeutics, Molecular drug targets and delivery, Pharmaceutical Development, Toxicology, Hospital Pharmacy, Organic and Inorganic Chemistry, Veterinary Pharmacy
Eintrags-ID:
1360647
19
CDD — CHI's Drug-Diagnostics Co-Development
24. Aug 2021 - 25. Aug 2021 • Washington, DC, Vereinigte Staaten
Veranstalter:
Cambridge Healthtech Institute (CHI)
Zusammenfassung:
This conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies will be presented. This conference is part of the Next Generation Dx Summit.
Kontakt:
Tel.: [781-972-5400];     Email: reg@healthtech.com
Themen:
drug, diagnostics, drug-diagnostics, medicare, drug reimbursement, diagnostic reimbursement, technology, technologies, lab tests, pharmaceuticals, biomarkers, immuno-oncology, precision medicine
Eintrags-ID:
1411719
Verwandte Fachgebiete:
20
IDX — CHI's Advanced Diagnostics for Infectious Disease
25. Aug 2021 - 26. Aug 2021 • Washington, DC, Vereinigte Staaten
Veranstalter:
Cambridge Healthtech Institute (CHI)
Zusammenfassung:
At this conference, leaders working in the clinical lab, research, biotech, and pharma will come together to showcase the latest in diagnostic technology and find solutions for the biggest challenges facing the clinical lab, including managing workflow, incorporating NGS and molecular testing, gaining reimbursement and regulatory approval, and more. This conference is part of the Next Generation Dx Summit.
Kontakt:
Tel.: [781-972-500];     Email: reg@healthtech.com
Themen:
diagnostics, advanced diagnostics, infectious diseases, infectious disease testing, molecular diagnostic test, MDx test, COVID-19, CRISPR, pandemics, POCT
Eintrags-ID:
1411651
Verwandte Fachgebiete:


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Stand vom 19. April 2021