Good manufacturing practice

6-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan (August 11, 2021) - ResearchAndMarkets.com

Friday, June 11, 2021 - 2:00pm

The "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" training has been added to ResearchAndMarkets.com's offering.
  • This 6-hrs webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program.
  • 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.
  • Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.

MediPharm Labs Extends Strategic Partnership with ADREXpharma and continues to Build its Presence in Germany

Tuesday, June 8, 2021 - 12:01pm

MediPharm and ADREX pioneered and progressed German regulatory acceptance of EU GMP cannabis API and finished dosed products from Canada and Australia.

Key Points: 
  • MediPharm and ADREX pioneered and progressed German regulatory acceptance of EU GMP cannabis API and finished dosed products from Canada and Australia.
  • With our global platform purpose built to good manufacturing practices, MediPharm has established a strong foothold in the nascent, but burgeoning, German cannabis market, said Keith Strachan, President and Interim CEO, MediPharm.
  • Our collaboration with ADREX has been an important and strategic step in our growth in this attractive market.
  • Our mission is to serve and offer the best therapeutical options to all patients in need in Germany.

Genix Pharmaceuticals Corporation Provides a Corporate Update to Shareholders

Monday, June 7, 2021 - 1:30pm

Vancouver, British Columbia--(Newsfile Corp. - June 7, 2021) - Genix Pharmaceuticals Corporation (TSXV: GENX) ("Genix" or the "Company").

Key Points: 
  • Vancouver, British Columbia--(Newsfile Corp. - June 7, 2021) - Genix Pharmaceuticals Corporation (TSXV: GENX) ("Genix" or the "Company").
  • President, Mr. Mahmoud S. Aziz, provides corporate update.
  • To the Shareholders of Genix:
    As the newly elected Director and President of Genix, I am pleased to provide you an update on our advancements and planned milestones.
  • Genix products are developed and supported by evidence-based science and clinical studies and manufactured under the strictest Good Manufacturing Practices (GMP) protocols.

SNF China Receives EFfCI GMP Certification

Friday, May 28, 2021 - 1:38pm

TAIXING, China, May 28, 2021 /PRNewswire/ --On April 27, 2021, the SNF Taixing (China) Cosmetic Ingredients plant received EFfCI (European Federation of Cosmetic Ingredients) GMP certification.The GMP (Good Manufacturing Practices) certification confirms that strict product quality and hygiene standards during manufacturing are followed.As a result, consumers can expect the highest quality and safety standards from SNF Taixing.

Key Points: 
  • TAIXING, China, May 28, 2021 /PRNewswire/ --On April 27, 2021, the SNF Taixing (China) Cosmetic Ingredients plant received EFfCI (European Federation of Cosmetic Ingredients) GMP certification.The GMP (Good Manufacturing Practices) certification confirms that strict product quality and hygiene standards during manufacturing are followed.As a result, consumers can expect the highest quality and safety standards from SNF Taixing.
  • SNF has dedicated resources at all levels of the organization, with active training and participation from R&D, Manufacturing, Quality, Regulatory, Sales & Marketing, Supply Chain, and Purchasing for this certification effort.With the Taixing certification, all of the SNF Cosmetic Ingredients manufacturing plants in France, U.S.A, and China are now EFfCI GMP certified.This will enable SNF to better service
    With turnover of $3 Billion, SNF is the world's leading manufacturer of water-soluble polymers and associated monomers, SNF has major production sites in the U.S.A. (Riceboro, GA; Plaquemine, LA; Pearlington, MS); Europe (France, UK); and Asia (China, India, Korea), with many smaller plants located throughout the world.
  • Most of the applications SNF targets involve cleaning or saving water.SNF is a pioneer of soft chemistry with manufacturing processes designed to minimize environmental impact.
  • If you would like more information on this topic, please contact Pascal Boehm, Specialty Sales Manager, SNF S.A. 310993@email4pr.com or +33 477 368 665
    View original content to download multimedia: http://www.prnewswire.com/news-releases/snf-china-receives-effci-gmp-cer...

Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Medical Products Administration

Monday, May 24, 2021 - 8:56am

The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.

Key Points: 
  • The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.
  • The Company also passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Guangdong Medical Products Administration.
  • Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company.
  • It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.

Vivos Inc Enhances Radiogel™ Manufacturing Process

Monday, May 24, 2021 - 2:30pm

Richland WA, May 24, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), During the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel.

Key Points: 
  • Richland WA, May 24, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), During the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel.
  • Full FDA pedigreed pre-clinical testing and clinical trials require Good Manufacturing Practice (GMP) protocols described in detail in FDA regulations.
  • The production improvements for Radiogel discussed were identified as part of establishing the GMP protocols for the IDE submission to the FDA.
  • Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet) and in humans (RadioGel).

Basic GMP Training for the QC Laboratory: Three Day Online Course (August 11-13, 2021) - ResearchAndMarkets.com

Monday, May 24, 2021 - 10:53am

The "Basic GMP Training for the QC Laboratory" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Basic GMP Training for the QC Laboratory" conference has been added to ResearchAndMarkets.com's offering.
  • This three-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control laboratories.
  • The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance.
  • Upon completion of this course, you will:
    Have an understanding the what, how and why of laboratory equipment qualification and methods validation

Miravo Healthcare™ Announces Director Election Results of its Annual Meeting of Shareholders

Monday, May 17, 2021 - 7:46pm

The Company's full report of voting results on matters presented at the Meeting can be found at www.sedar.com .\nMiravo is a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products.

Key Points: 
  • The Company's full report of voting results on matters presented at the Meeting can be found at www.sedar.com .\nMiravo is a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products.
  • The Company's products target several therapeutic areas, including pain, allergy, neurology and dermatology.
  • The Company's strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets.
  • The Varennes facility operates in a Good Manufacturing Practices (GMP) environment respecting the U.S., Canada and E.U.

2-Day Instructor-Led Virtual Seminar on FDA Inspection Essentials (June 1-2, 2021) - ResearchAndMarkets.com

Wednesday, May 12, 2021 - 9:45am

b'The "2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021" conference has been added to ResearchAndMarkets.com\'s offering.\nThe purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance.

Key Points: 
  • b'The "2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021" conference has been added to ResearchAndMarkets.com\'s offering.\nThe purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance.
  • The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.
  • Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard.
  • Personnel training is one key variable that should be looked at prior to any inspection.

UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)

Wednesday, May 12, 2021 - 9:15am

The Company also provided a process update on the DCVax-L Phase III Trial.\nOn May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients.

Key Points: 
  • The Company also provided a process update on the DCVax-L Phase III Trial.\nOn May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients.
  • Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA.
  • The Company appreciates shareholders\' patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results.
  • "This Phase III trial is now completed, with the trial data now being analyzed.The Company is also pursuing development of DCVax-Direct for inoperable solid tumor cancers.