Calendar of Events

It is LSAM's goal to thoughtfully create networking opportunities directly related to the needs and interests of members while providing an opportunity for Manitoba's life science community to come together as an industry.  Additionally, we strive to inform members of events occuring beyond our borders as a means of exploring new partnership and furthering our knowledge.

• International Benchmarking Conference

  Benchmarking is the process of comparing one’s business processes and performance metrics to industry bests and/or best practices from other industries. Participants will learn how well the targets perform and, more importantly, the business processes that explain why these firms are successful.

  02-03-2012 Read More

• Introduction to Statistical Analysis of Laboratory Data

  This course is designed as an introduction to the statistical principles of laboratory data analysis and quality control that form the basis for the design and analysis of laboratory investigations.

  01-03-2012 - 02-03-2012 Read More

• Clinical Document Management- A Trial by Trial Approach to Compliance

  Conducting clinical trials and accruing accurate and viable data is the most expensive component of the drug development paradigm. Clinical teams are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete.

  01-03-2012 - 02-03-2012 Read More

• An Overview of the FDA's "New" Process Validation Guidance

  The instructor is Barry A. Friedman Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095.

  05-03-2012 Read More

• Preparation of FDA Submissions and Communicating with the FDA

  Personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) will find this course to be of particular benefit. Those who need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel, will also find this course extremely useful.

  05-03-2012 - 06-03-2012 Read More

• Cleanroom Microbiology for the Non-Microbiologist

  This is an introductory course that is designed for management and staff involved in cleanroom operations who will benefit from a better understanding of how microbiology impacts cleanroom technology. Although this course will benefit experienced cleanroom personnel, it is primarily designed for those who require a basic understanding of cleanroom operations. The

  05-03-2012 - 06-03-2012 Read More

• Introduction to Medical Combination Products

  This course will be most valuable to medical device/product professionals who need a firm understanding of how to gain FDA approval for combination products. The course is geared toward personnel that are newer to the industry or need to gain perspective of how to develop a successful combination product.

  05-03-2012 - 06-03-2012 Read More

• Lot Disposition in a Clinical and Commercial Setting – Meeting US, Canada and EU Regulatory Expectations

  The instructor is Peter Calcott Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095.

  06-03-2012 Read More

• Canadian Innovation Commercialization Program Information Session

  This program has been cancelled

  07-03-2012 Read More

• Introduction to Molecular Biology Techniques

  This is a three-day course for those interested in learning both fundamental and advanced-level molecular biology techniques. Molecular biology methods are used extensively in modern day drug discovery, research and development, and diagnostics. This course is intended for personnel with some scientific background who are seeking basic and advanced-level molecular biology training and who wish to become conversant within the discipline.

  05-03-2012 - 07-03-2012 Read More

• Medical device registration in India

  About the presenter: Bryan Gilburg is VP of Business Development, Asian Markets, for Emergo Group, an international medical device firm focusing on regulatory compliance, quality management systems, in-country representation, clinical studies and distributor search services.

  07-03-2012 Read More

• 5TH ANNUAL BIOMASS WORKSHOP

  With the implementation of Manitoba's coal burning emission tax for 2012, biomass production and usage is becoming increasingly favoured.

  08-03-2012 Read More

• Introduction to Medical Device Submissions

  This course will be most valuable to medical device/product professionals who need an understanding of how to get medical devices into the US market while respecting FDA regulations. The course is geared toward professionals that are newer to the industry or who need to gain an understanding of submissions for the first time.

  07-03-2012 - 08-03-2012 Read More

• Sterilization Procedures Technology , Equipment & Validation

  This is a basic course covering the microbial, scientific, technological, and statistical foundations of sterilization methods. The purpose of the course is to provide fundamental information on the application of sterilization methods in production processes for technicians, engineers, cleanroom designers, and supervisors.

  07-03-2012 - 08-03-2012 Read More

• OOS Investigations

  The instructor is John G. (Jerry) Lanese, Ph.D, CMC presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095. Investigation of any discrepancy or deviation is and expectation of all regulatory agencies. This includes the follow-up of confirmed OOS laboratory observations.

  08-03-2012 Read More

• Validation of Computer Systems

  This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems.

  08-03-2012 - 09-03-2012 Read More

• Have your say on Health Care

  Please join us for an informative and thought-provoking dialogue on healthcare at one of the community forums .

  12-03-2012 Read More

• Have your say on Health Care

  Please join us for an informative and thought-provoking dialogue on healthcare at one of the community forums.

  13-03-2012 Read More

• Design Control for Medical Device Professionals

  This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Design Control per the FDA's CFR 810.30. The course also provides context for 810.30 vs. the Design Control part of ISO 13485:2003.

  12-03-2012 - 13-03-2012 Read More

• CHI's Third Annual Encouraging Development of Therapeutics for Neglected Diseases

  In order to make a significant impact in targeting neglected tropical diseases, many issues are at stake and need to be addressed. Which diseases are most prevailing and which present newly emerging targets for developing therapeutics? Are there novel opportunities for collaborations?

  12-03-2012 - 13-03-2012 Read More

• Design Validation, Verification, and Risk Analysis for Medical Device Professional

  Upon completion of this course, attendees will have an understanding of the framework for Design V&V, Risk Analysis and recommendations to effectively meet the regulatory requirements relating to these. Emphasis will be placed not only on regulatory aspects, but on effective strategy, which is very important to avoid spending unnecessary time and money on ineffective techniques while ensuring that the requirements for medical products are met successfully.

  14-03-2012 - 15-03-2012 Read More

• The New CBER Sterility – A Comprehensive Review of Sterility Testing

  The instructor is Barry A. Friedman Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095.

  15-03-2012 Read More

• Preparing the CMC Section for NDAs/INDs/CTDs

  This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product.

  15-03-2012 - 16-03-2012 Read More

• Biostatistics for Non-Statisticians

  This course is designed as an introduction to the statistical principles that form the basis for the design and analysis of research investigations in pharmaceutical and medical device studies. The focus of topics will benefit individuals within the pharmaceutical, biotech and device industries including medical investigators, basic and clinical research scientists, clinical research associates those involved in regulatory affairs.

  14-03-2012 - 16-03-2012 Read More

• The Drug Development Process-from Discovery to Commercialization

  Designed for employees who need an understanding of the drug development process, this course provides a detailed picture of the complex and highly interrelated activities of the development cycle for drugs and biologics, from discovery to a successful commercialization. The training will be beneficial for anyone involved in the R&D process. It can also be customized for marketing & sales personnel who need to understand that actions taken during the development process have a significant effect on sales and marketing strategies.

  14-03-2012 - 16-03-2012 Read More

• Rapid Microbiological Methods

  The instructor is Michael J. Miller Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095. Rapid method technologies can detect the presence of diverse types of microorganisms or a specific microbial species, enumerate the number of microorganisms present in a sample, and can identify microbial cultures to the genus, species and sub-species levels.

  19-03-2012 Read More

• Selecting and Managing CROs

  This two-day seminar is designed for personnel in the pharmaceutical, biotechnology, medical device and biologics industries who use Contract Research Organizations (CROs) in the process of developing their products for FDA approvals. Attendees should have a basic knowledge of the drug, device or biologics development processes and a need to understand what is involved in outsourcing non-clinical and clinical research to CROs.

  19-03-2012 - 20-03-2012 Read More

• Good Clinical Practices Compliance

  The instructor is Peter Calcott Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095.

  20-03-2012 Read More

• Capital Breakfast

  Raising capital is one of the great challenges innovative companies face. Join LSAM and our speakers as they discuss investing in companies from early stage research, through to commercialization.

  21-03-2012 Read More

• Good Clinical Practices (GCPs)

  This course is specifically designed for Clinical Research Monitors (CRMs), Clinical Research Auditors and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Clinical Practices (GCPs). This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guidelines.

  19-03-2012 - 21-03-2012 Read More

• Lyophilization Technology- Practical Application of the Scientific Principles

  Upon completion of this course, attendees will have a clear understanding of both the scientific and practical principles behind the formulation and development of lyophilized products. Additionally, participants will gain a firm understanding of lyophilization equipment including system operation, system components, system maintenance, system troubleshooting, IQ/OQ, and system validation.

  19-03-2012 - 21-03-2012 Read More

• cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

  The course helps the cGMP beginner by presenting important concepts in a logical and natural sequence so they can begin to understand the concepts and begin applying them. The course also helps the both the “cGMP Intermediate” and the “cGMP Professional” by providing valuable insights that will assist them in quality decision-making, as well as, demonstrating ways to make their present systems more effective.

  19-03-2012 - 21-03-2012 Read More

• Medical device approval and BGMP compliance in Brazil

  About the presenter: Ann Marie Boullie is Director of Business Development, Latin America, for Emergo Group, an international medical device firm focusing on regulatory compliance, quality management systems, in-country representation, clinical studies and distributor search services. This webinar will be conducted in English.

  21-03-2012 Read More

• Batch Record Review Process- 2012 Requirements

  The instructor is Peter Calcott Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095. Before product can be released to clinic or commerce, it must be examined to assure it meets its pre-defined requirements. One element is the Batch Record Review process.

  21-03-2012 Read More

• Doing Business in India

  Are you interested in doing business with one of the most rapidly grow regions in the world. Join us and learn more about doing business in India.

  22-03-2012 Read More

• Writing Effective Standard Operating Procedures and Other Process Documents

  This is a course for people who must write process documents required by the binding regulations. Process documents in sum create a procedural infrastructure that delineates the company’s activities. These documents include Standard Operating Procedures (SOPs); policies; work instructions; laboratory methods; emergency action, chemical hygiene, animal husbandry and other plans; and quality manuals.

  22-03-2012 - 23-03-2012 Read More

• Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

  This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

  26-03-2012 - 27-03-2012 Read More

• Writing in the Regulated Environment When English Is Your Second Language

  This is a course for people whose native language is other than English and who must write documents in support of therapeutic product development or regulatory submissions.

  26-03-2012 - 27-03-2012 Read More

• Pharmaceutical Production Batch Record Review

  Upon completion of this course, attendees will gain a clear understanding of the batch record review expectations of regulatory agencies and discover the elements of an effective batch record reviewer training program.

  26-03-2012 - 27-03-2012 Read More

• Process Validation for Drugs and Biologics

  Attendance will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who will eventually participate in validation efforts.

  26-03-2012 - 27-03-2012 Read More

• BIC International Conference: Bringing Bioproducts to Market

  Join us in the home of Canada's emerging hybrid chemistry cluster to share up-to-date information about best practices in the bio-economy.

  26-03-2012 - 28-03-2012 Read More

• Developing an Autoclave Validation Plan

  The instructor is Barry A. Friedman Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095. Terminal moist heat sterilization is presently considered the method of choice to ensure sterility. An autoclave validation plan and its implementation are considered critical elements of any Site Validation Plan in a cGMP environment to assure this sterility.

  28-03-2012 Read More

• DRIVE FOR FREE - The Alternative Fuel Revolution

  Plan to attend the Premiere Screening of "Drive for Free - The Alternative Fuel Revolution"

  28-03-2012 Read More

• Intro to Boston; A Gateway to BIO

  Want to learn more about working in Boston? We have assembled a team of experienced consultants who are active participants in the life sciences community and have significant experience in targeted matching of these types of companies in the Boston area and globally.

  29-03-2012 Read More

• Overview of FDA Regulatory Compliance for Medical Devices

  This course has been developed for those who are involved with ensuring regulatory compliance for medical devices. Participants ranging from new hires to industry veterans who need a baseline understanding of medical device regulatory compliance issues will benefit from this course.

  28-03-2012 - 29-03-2012 Read More

• Project Management for Phase 3 and LCM of the Drug Development Process

  This course will provide value to those in the Pharmaceutical, Biotech and Medical Device industries who manage or direct projects within their functional area related to Clinical Trials. It will also benefit personnel that need an understanding of industry specific and project management best practices that should apply to their project.

  28-03-2012 - 29-03-2012 Read More

• Use and Application of Sanitizers, Disinfectants and Sterilants in a cGMP Controlled Environment

  The instructor is Barry A. Friedman Ph.D presented by Tungsten Shield Group. To register and receive a generous discount from our partner The Tungsten Shield Group, please contact Andrea Perrin at 272-5095.

  29-03-2012 Read More

• Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries

  Scientists, engineers, and technicians in research and development will find this course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals. This course is also useful for administrative staff that must prepare documentation in support of R&D and operations activities.

  28-03-2012 - 30-03-2012 Read More