Webinar Takeaway
Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar
- Key Guidances on Cybersecurity
- Draft Guidance on Data Integrity
- How the CGMPs are Affected
- FDA’s enforcement approaches
- System vunerablities, Cloud, updates and other concerns
- "Documented at Time of Performance"
- "Backup Data" - the uncommon meaning
- Storage and retrieval"
- "Original records,” “true copies,” or other “accurate reproductions"
- Validation and unique documentation requirements
Who Will Benefit
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
- All personnel involved in the U.S. FDA-regulated (CGMPS) and CE-marking (EU MDR) environments. Especially those involved in new medical product / combination product development, line extensions, and incremental product improvements; having to address data integrity and cybersecurity and validate and then document their decisions in harmony with regulations.
Overview
With increased requirements for documentation, and increassd reliance on electronic records, the need for data integrigy and cybersecurity has grown. The threat to electronic records, computer-controlled manufacturing, and medical devices has correspondingly grown as well. As a result, the US FDA has issued several Guidances for Industry on data integrity and cybersecurity.
This webinar will focus on their expectations for industry. Data Integrity has always been a CGMP priority; Cybersecurity is coming under increased regulatory review. The Agency leaves the how of compliance up to the manufacturer, as long as the principles in the guidances are met in the resulting product and/or system; and on electronic-specific tools / techniques to achieve CGMP compliance .
Updates, upgrades, new revisions / releases, service packs, and similar are automatically uploaded to a company’s systems, which can pose security risks, with the potential for introduction of compromised code, retrieval of confidential data, data integrity issues, and similar; and render previous computer systems’ verification and validations worthless. This webinar will consider how data integrity and cybersecurity must be a major consideration of the CGMPs, design control, documentation, and post-production by the CAPA system, among others.
Why Should You Attend
Data integrity has always been a key component of all the CGMPs, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized access. A growing concern for all – legal, financial, consumer, personal, and the FDA. t's a recent concern for the medical products industries, a result of growing requirements for documentation / record keeping and companies increased reliance on networked electronic software, records and signatures.
The CGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But they are insufficient to prevent this growing threat. The FDA and news media have emphasized the prevalence of cybersecurity issues, such as data / identity theft, and hacking which pose hazards to many activities and businesses / industries.
Cybersecurity is an issue that will only increase over time, as records become more electronic, and communications are more networked or accessible to outsiders / hackers. As a result the FDA has mandated further requirements to be taken by regulated industries to better control data integrity and the cybersecurity threat, in validations, CGMP documentation, submissions to the Agency .
Industries who can attend
This 180 -minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 39 years experience in U.S. FDA-regulated industries, 25 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on virtually all CGMP issues. John is a graduate of UCLA.
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.