Charlie Wakeham Email & Phone Number

Sydney, Nsw, Au

WakeUp to Quality offers expert GxP consultancy services including computerized systems validation, data integrity assessments, QMS improvements, and training.

North Bethesda, Maryland, Us

North Bethesda, Maryland, Us

Providing a 'safe place' for ISPE members to discuss CSA approaches and share real life experiences of critical thinking and innovative testing techniques

North Bethesda, Maryland, Us

GAMP Global Steering Committee is the governing body of GAMP Community of Practice's 5,000 members and their activities worldwide within ISPE. It develops and maintains forward strategy aligned to the ISPE strategic plan, and delivers industry-recognized good practice guides, educational session and conferences and leads special interest working groups (SIG) for like-minded professionals. GAMP Global Steering Committee drives continuous improvement and facilitates the application of new ideas and technologies in the fields of Computerized Systems Validation and Data Integrity.(¯`*•. 🏆 The GAMP Global Steering Committee was awarded 𝗖𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗬𝗲𝗮𝗿 at the ISPE 2022 Annual Meeting in Orlando.

North Bethesda, Maryland, Us

North Bethesda, Maryland, Us

Charlie worked with 5 other SMEs to lead a team of 100+ industry members (the GAMP Data Integrity Special Interest Group) working on defining and explaining the requirements for Data Integrity in regulated organizations. The SIG focussed on creating articles in journals, concept papers and good practice guides to promote data integrity, and was sunset in December 2021. Charlie's activities within the Leadership Team included: ⇨ Co-lead on the GAMP Guide: 𝘋𝘢𝘵𝘢 𝘐𝘯𝘵𝘦𝘨𝘳𝘪𝘵𝘺 𝘣𝘺 𝘋𝘦𝘴𝘪𝘨𝘯, published October 2020 ⇨ Co-lead on the GAMP Guide: 𝘋𝘢𝘵𝘢 𝘐𝘯𝘵𝘦𝘨𝘳𝘪𝘵𝘺 𝘧𝘰𝘳 𝘔𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘪𝘯𝘨 𝘙𝘦𝘤𝘰𝘳𝘥𝘴, published May 2019 ⇨ Co-lead on the GAMP Guide: 𝘋𝘢𝘵𝘢 𝘐𝘯𝘵𝘦𝘨𝘳𝘪𝘵𝘺 - 𝘒𝘦𝘺 𝘊𝘰𝘯𝘤𝘦𝘱𝘵𝘴, published October 2018 ⇨ Workshop leader at ISPE 2018 Annual Meeting, Philadelphia, ⇨ Workshop leader at ISPE Singapore Annual Meeting 2018 ⇨ Data Integrity presenter at Global Bio Conference, Seoul 2018 ⇨ Industry presenter at PIC/S Seminar 2017 on Data Integrity in Quality Control laboratories ⇨ Session leader at ISPE 2017 Annual Meeting, San Diego ⇨ Contributor to the ISPE GAMP 𝘙𝘦𝘤𝘰𝘳𝘥𝘴 𝘢𝘯𝘥 𝘋𝘢𝘵𝘢 𝘐𝘯𝘵𝘦𝘨𝘳𝘪𝘵𝘺 𝘎𝘶𝘪𝘥𝘦, published 5 April 2017 (¯`*•. 🏆 The Leadership Team was awarded 𝗖𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗬𝗲𝗮𝗿 at the ISPE 2017 Annual Meeting in San Diego.

Melbourne, Victoria, Au

Charlie had global responsibility for improving organizational quality, implementing project quality, and safeguarding data privacy to DPA/GDPR, while maintaining QMS and certification in support of ISO 9001, ISO 20000-1, ISO 22301, and ISO 27001.During her time at Magentus, she introduced, formalised, and operationalised clinical risk management processes into the Australian development and support teams based on UK NHS standards, as well as refreshing the risk management process globally under ISO 31000. She initiated and presented Quarterly Quality All-Hands meetings to raise Quality awareness throughout the organisation and was a strong proponent of GAMP methodologies to improve the SDLC.

Milford, Ma, Us

Charlie proactively leveraged her extensive ISPE GAMP volunteer activities creating industry best practice guidance and monitoring regulatory trends to enhance Waters product positioning, marketing strategies and technical features. She applied her computerized systems validation and data integrity expertise to drive continual improvements in the delivery of Waters CSV projects for Empower, NuGenesis and UNIFI in the APAC region.

Milford, Ma, Us

Charlie built and developed the Professional Services business in APAC for Waters, and she and her team of CSV consultants delivered high-quality on-site and remote computer system validation services across the whole of Asia Pacific, for the following Waters laboratory informatics solutions:● Empower Enterprise Chromatography Data System, ● NuGenesis Laboratory Management System● UNIFI Scientific Information System.

Port Washington, New York, Us

Charlie's primary responsibility was developing innovative instrumentation systems with her department in Portsmouth, UK. She also provided pragmatic, efficient solutions to the regulatory requirements for new computerised system developments for QC laboratories, pharmaceutical manufacturing, and bioprocessing, for project teams in California, Michigan, and France.(¯`*•. 🏆 During this time, Charlie qualified as an ISO9001 Lead Auditor, and twice received the 𝗣𝗮𝗹𝗹 𝗣𝗿𝗲𝘀𝗶𝗱𝗲𝗻𝘁'𝘀 𝗔𝘄𝗮𝗿𝗱 𝗳𝗼𝗿 𝗼𝘂𝘁𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗰𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻.

Port Washington, New York, Us

Highlights during this time were:⇨ Qualification in Project Mangement (APMP / IPMA Level D)⇨ Formal training in Risk Management (accredited by the Institute of Risk Management)⇨ Mentoring graduate engineers⇨ Elected to the grade of 𝗙𝗲𝗹𝗹𝗼𝘄 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗻𝘀𝘁𝗶𝘁𝘂𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗰𝗵𝗮𝗻𝗶𝗰𝗮𝗹 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝘀

Port Washington, New York, Us

Charlie moved to the newly-created Instrumentation Technology department to focus on developing benchtop process and analytical instruments. This gave Charlie the opportunity to develop her knowledge base to include:♦ Quality: creating a departmental quality management system in accordance with ISO9001.♦ Supplier Management: all design and manufacture was undertaken by sub-contract suppliers♦ Marketing and Technical Support: to prepare the launch documentation and product literature

Port Washington, New York, Us

This role was Charlie's introduction to both the pharmaceutical industry and to process control system design/build. Charlie's main responsibilities included customer negotiation, quotation, process specification, design, manufacture and validation of systems for the pharmaceutical and food & beverage industries. She supervised mechanical, electrical and control system design, and specified and sourced specialist components, and performed Factory Acceptance Testing and commissioning.

North Bethesda, Maryland, Us

Charlie's role supported the European Chair in developing the business strategy and direction for GAMP Europe, to promote knowledge sharing and improved regulatory compliance across the pharmaceutical industry in Europe and beyond.

North Bethesda, Maryland, Us

Charlie was one of the original founding members of the steering committee, and played a key role in organising the twice-yearly GAMP UK one-day seminars for the first three years of GAMP UK.

Master Of Science (M.Sc.), Advanced Manufacturing Technology

Bachelor Of Engineering (B.Eng.), Mechanical Engineering