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- Draft Guidance on Data Integrity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
- 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.
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.